Cases of type 2 diabetes have been significant and on the rise within the past decade. This condition is restrictive in some ways. Individuals are deprived of the ability to enjoy their preferred foods and are likely to experience intense symptoms (i.e., thirst, hunger, faintness, and blurred vision, among others). Several solutions have come and gone, but one natural supplement appears to have taken a unique approach that might end up reversing diabetes altogether. This supplement is none other than Glucofort.

Glucofort is an advanced blood sugar support that eliminates the supposed root cause of type 2 diabetes: ceramides. As explained by the creators of this solution, Andrew Freeman and Dr. Jun, ceramides push fat cells into the bloodstream, forcing vital organs to clog up. This prevents the pancreas from producing the insulin hormone, a crucial component that redistributes glucose to other body areas. It is only when these foreign invaders are eliminated from the body that diabetes might be reversed altogether. Hence, the reason for Glucofort.

The Glucofort formula has been split into a vitamins and minerals blend and a proprietary blend. The first includes Vitamin C (50mg), Vitamin E (15mg), Biotin (300mcg), Magnesium (125mg), Zinc (7.5mg), Manganese (1mg), Chromium (76mcg) and Vanadium. As for the proprietary ingredients blend, individuals can familiarize themselves with Guggul, Bitter Melon, Licorice, Cinnamon, Gymnema Sylvestre, Alpha Lipoic Acid, Banaba, Yarrow, Juniper, White Mulberry, L-Taurine, and Cayenne.

Guggul: According to a 2020 article in the International Journal of Research in Pharmaceutical Sciences, Guggul divided into nine groups, rats were given Diabetes mellitus, over a 28 week period, Blood collected showed that guggul did not reveal toxicity in the rats, and guggul formulations improved oral glucose tolerance in the diabetes-induced rats and after the end of the study resulted in significant reductions in serum glucose levels.

Bitter Melon: The US National Library of Medicine National Institutes of Health states that medicinal plants are important cost-effective worldwide to treat diabetes and are considered therapeutic aids in alleviating ailments in humans. Bitter melon is reported to possess pancreatic cell regeneration, insulin-releasing, and fighting insulin resistance.

Licorice Root: An herb that has been used for decades to treat many health ailments. Scientists have identified a group of natural substances with anti-diabetic effects found in the licorice root.

Cinnamon Bark: Known as true cinnamon, studies show that cinnamon can effectively manage blood sugar issues, such as lower blood sugar, and may help control high blood glucose levels in the brain.

Gymnema Sylvestre: Supports lowering of high blood sugar levels. And may play a role in diabetes treatment, as it may regenerating pancreas islet cells and stimulate insulin secretion, which help lower blood sugar levels.

Alpha Lipoic Acid: Can break down carbs and make energy for use in other organs in the body, and an antioxidant.

Banaba: The banaba leaf has been used in folk medicine for decades to treat diabetes used for its impressive anti-diabetic properties, antioxidant, cholesterol-lowering, and anti-obesity health benefits.

Yarrow: Used to regulate blood sugar in diabetes, protect the gallbladder and liver, and as immune-system support.

Juniper Berry: May hold antidiabetic properties and used in traditional medicine to treat diabetes, with recent studies confirming that they may have anti-diabetic properties.

White Mulberry: Used to treat high cholesterol, common colds, high blood pressure, joint, and muscle pain caused by arthritis. White mulberry can be used against hair loss and premature graying, constipation, dizziness, and ringing in the ears.

L-Taurine: Taurine can helps by avoiding the damaging effects of fat, glucose, and excess insulin levels; it also protects and strengthens the heart muscle cells.

Cayenne: Scientifically proven to boost metabolism, lower blood pressure with the capsaicin found in cayenne peppers can also reduce hunger.

Generally speaking, Glucofort is deemed 100% natural, safe, and effective to take. In fact, this formula has supposedly undergone testing with 160 men and women who were either pre-diabetic, diabetic, or have had diabetes for some time now. The study results suggest that glucose levels improved, weight and fat loss were attained, blood pressure and sugar levels were lowered, and cardiovascular and cognitive health bettered with time. That said, no side effects were reported. All things considered, a health practitioners opinion should be gathered before adding any extra supplements.

Given that one capsule should be taken per day and each bottle contains 30 capsules, individuals can expect to invest roughly $69 per bottle. Bulk orders such as purchasing 3 or 6 bottles at once will come out to $59 and $49 each, respectively. Luckily, all unused bottles have been protected by a 60-day money-back guarantee, making Glucofort risk-free.

Blood sugar is a health biomarker that needs to be taken care of, as it can easily worsen and lead to unwanted health implications. With a solution like Glucofort, symptoms may be eased in the short run and reversed in the long run. In this case, patience is key, and everyone will need to consider their health conditions and possible medication interactions beforehand. To find out more about Glucofort, visit here>>>.

More Like This: What is Gluco Shield Pro?

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Disclaimer:

Please understand that any advice or guidelines revealed here are not even remotely a substitute for sound medical advice from a licensed healthcare provider. Make sure to consult with a professional physician before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary as the statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease.

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GlucoFort Reviews: Does GlucoFort Work? What They Won't Say! - Homer News

Recommendation and review posted by Bethany Smith

Introduction

Prostate cancer is the fifth most common cancer in Thai men,1 and the number of cases continues to increase despite active screening. Radical prostatectomy (RP) is the standard of care in the management of clinically localised cancer and also an option for the treatment of locally advanced prostate cancer. RP can be performed using open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), or robotic-assisted laparoscopic radical prostatectomy (RALRP) techniques.

Another recognised treatment for regional and metastatic prostate cancer is androgen deprivation therapy (ADT). ADT is also a beneficial supplement to external beam radiation therapy (EBRT).2 However, the use of neoadjuvant androgen deprivation therapy (NADT) prior to RP as a perioperative treatment is still controversial.2 Previous research has demonstrated that NADT lowers the positive margin status, but this benefit has not translated into improvements in long-term PSA-free survival.3 NADT is also associated with worrisome side effects, such as osteoporosis, hot flashes, sexual dysfunction, metabolic syndrome, gynecomastia, anaemia and cardiovascular mortality. For all these reasons, current guidelines recommend against the use of NADT prior to RP.2,4,5

In the past few years, a growing trend has emerged towards the utilization of NADT, as it can provide a pathological complete response,6 a potentially positive impact on recurrence rates,7 a significant decrease in prostate cancerrelated death8 and fewer long-term effects on quality of life.9 The aim of the present study was to determine the benefit of NADT prior to RP in terms of perioperative outcomes.

Between January 2008 and July 2018, 718 prostate cancer patients were treated by RP at Ramathibodi Hospital in Thailand. Of these patients, 138 had undergone NADT (NADT group) and 580 had not undergone neoadjuvant ADT (non-NADT group). The remaining 2 patients were excluded from the study due to incomplete data. The principles of the Helsinki Declaration were followed during the study, consent and the confidentiality of the patients data was maintained by the authority of the Committee for Research of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University (date of approval: 20 February 2020, ID MURA2020/298).

The ORP was performed in a retropubic fashion via low midline incision (Figure 1). A retzius space was approached with blunt and sharp dissection along the outside of left umbilical ligament. Endopelvic fascia on both sides were bluntly opened, puboprostatic ligament was dissected and dorsal venous complex was sutured and ligated using Vicryl No.1. The bladder neck was incised with monopolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were dissected with monopolar cautery and ligated without nerve sparing, followed by incised of urethra by Metzenbaum scissor. An urethrovesical anastomosis was performed with interrupted sutures, using Vicryl 3/0 6 stitches. Before the last stitch was performed, new 20 Fr Foleys catheter was inserted via urethra into bladder. Bleeding was checked and stopped. Silastic drain was placed in cul-de-sac.

Figure 1 Incision of open radical prostatectomy.

The LRPs were performed in an extraperitoneal fashion using 5 trocars with some modification in port position to facilitate the prevention to graft injury (Figure 2). Subumbilical incision was done and extraperitoneal space was created using kidney-shaped balloons with (PDB, Covidien, United States). Retropneumoperitoneum was performed by CO2 insufflation to create at an abdominal pressure of 15 mmHg, followed by port placement as Figure 2, all trocars were inserted under direct visualization. Thirty-degree standard Trendelenburg position was used with cushioning for dependent zone. A Retzius space was developed. Endopelvic fascia on both sides were opened, followed by puboprostatic ligament was dissected and dorsal venous complex was controlled using Vicryl No.1 CT-1 needle. The bladder neck was incised with monopolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were controlled by Hem-o-lock clip and dissected with vessel sealing device (LigaSure Impact Curved, Large jaw, Medtronic, United Kingdom) without nerve sparing, followed by incised of urethra by cold scissor. An urethrovesical anastomosis was performed with continuous watertight sutures, using Vicryl 3/0. Before passing the anterior stitch, the 20 Fr Foleys catheter was passed into the bladder and the anastomosis was completed. A closed suction drain was placed in cul-de-sac. The specimen was retrieved with the use of laparoscopic bag through a subumbilical incision.

Figure 2 Port placement of laparoscopic radical prostatectomy.

The RALRPs were performed with transperitoneal fashion using the da Vinci Si Surgical System, with 5 trocars. We place the trocars medially than the standard port site to deliver sufficient access without graft injury (Figure 3). The pneumoperitoneum pressure of 15 mmHg was created after subumbilical puncture with Veress needle. A 12 mm subumbilical trocar was inserted into abdominal space and was used as a camera port. Two robotic trocars were placed on the right side with at least 8 cm apart from each other (Arm 1, Arm 3). On the left side, a robotic trocar was placed (Arm 2), and the assistance 12 mm trocar was inserted between the second port and camera port as Figure 3, all trocars were inserted under direct visualization. Each arm was equipped with Monopolar scissor (Arm 1), Bipolar Maryland (Arm 2) and Prograpse (Arm 3). Thirty-degree standard Trendelenburg position was used with cushioning for dependent zone. A Retzius space was developed. Endopelvic fascia on both sides were opened, followed by puboprostatic ligament was dissected and dorsal venous complex was controlled using barbed suture No.1 (V-Loc PBT wound closure device, Medtronic, United Kingdom). The bladder neck was incised with monopolar and bipolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were controlled by Hem-o-lock clip and dissected with monopolar and bipolar cautery with 1 case of interfacial nerve sparing and 2 case of non-nerve sparing, followed by incised of urethra by cold scissor. An urethrovesical anastomosis was performed with continuous watertight sutures, using barbed suture 3/0 (V-Loc PBT wound closure device, Medtronic, United Kingdom). Before passing the anterior stitch, the 20 Fr Foleys catheter was passed into the bladder and the anastomosis was completed. A closed suction drain was placed in cul-de-sac. The specimen was retrieved with the use of laparoscopic bag through a subumbilical incision.

Figure 3 Port placement of robotic-assisted radical prostatectomy.

Nerve-sparing RPs were performed in some cases, except when biopsy specimens revealed extensive cancer or in cases of preoperative poor-quality erections, current and future lack of a sexual relationship, or other medical conditions that could adversely affect erections (eg, hypertension, diabetes mellitus, neurologic diseases, psychiatric diseases or medications that produce erectile dysfunction). However, we shared the decision-making with the patients and the surgeon.

Six instructor surgeons participated in this study. Two surgeons always performed ORPs over 25 years, while the other four surgeons performed all three techniques as shown in Table 1. The procedure techniques were decided by shared decision-making with patients.

Table 1 Surgeons Participation

In this study, both gonadotropin-releasing hormone (GnRH) analogues, such as degarelix, and GnRH antagonists, such as leuprolide, goserelin and triptorelin, were used for the ADT. The choice of medication depended on the patients insurance and the surgeon preference. The duration of NADT was 3 months, since some evidence indicates that this is the optimum duration.10,11

The decision was made upon the discussion between patients and physicians. Since the specific criteria for selection have not been officially stated, we typically advise the NADT for those patients who a. associated with high or very high-risk disease and b. are on the waitlist for surgery longer than three months.

The following data were collected from all patients: age, body weight (kg), height (cm), body mass index (BMI), prostate-specific antigen (PSA) level, underlying disease, clinical stage (TNM classification), prostate cancer risk group (National Comprehensive Cancer Network [NCCN] classification),2 and the Gleason score (GS) of the biopsy specimen.

Perioperative outcomes included operative time (minutes); estimated blood loss (EBL) (mL); perioperative complications, including transfusion rate; adjacent organ injury of the bladder, rectum, ureter, bowel, or blood vessel; and length of hospital stay (days) (determined by subtracting the date of admission from the date of discharge).

All specimens were evaluated in accordance with the NCCN guidelines by an experienced uropathologist, who reported the prostate weight (g), pathological stage, GS of the specimen and the margin status. A positive surgical margin (PSM) was defined as cancer cells extending to the inked surface of the specimen.12

A descriptive study was performed. The data were analysed using a Wilcoxon rank-sum (MannWhitney) and Fishers exact test to identify the statistical significance of the difference in means standard deviation, median (interquartile range), and proportions. Analysis was performed using Stata version 14 software, with a p-value of <0.005 considered to be statistically significant.

The demographic data and preoperative parameters are presented in Table 2. The non-NADT and NADT groups were not statistically different in terms of median age (68 vs 68 years; p = 0.819), median body weight (67.1 vs 67.1 kg; p = 0.807), median height (165 vs 165 cm; p = 0.403) or median BMI (24.4 vs 24.3 kg/m2; p = 0.218). The pre-operative PSA level and GS of the biopsy specimens were statistically significantly higher in the NADT than in the non-NADT group (33.4 [16.256.6] vs 10.1 [7.215.2]; p = <0.001 and 8 [79] vs 7 [67]; p = <0.001). The clinical stage differed significantly between the two groups (p = <0.001).

Table 2 Demographic Data and Pre-Operative Parameters of Non-NADT and NADT

The perioperative outcomes (Table 3) showed that the operative time was significantly lower in the NADT than in the non-NADT group (185 vs 195 minutes; p = <0.018). The EBL was also significantly lower in the NADT than in the non-NADT group (300 vs 500 mL; p = <0.001), but no difference was noted in the blood transfusion rate between the two groups. No statistically significant differences were detected between the NADT and non-NADT groups for adjacent organ injury rate (2.9% vs 2.2%; p = 0.999) or length of hospital stay (6 vs 6 days; p = 0.184). The most common site of injury was the rectum (11 patients).

Table 3 Perioperative Outcomes of Non-NADT and NADT

The pathological outcomes (Table 4) revealed significant differences in pathological stage between the two groups (p = 0.001). The GS of the specimens was significantly higher in the NADT group than in the non-NADT (7 [79] vs 7 [77]; p < 0.001). The specimen weight was significantly lower in the NADT than in the non-NADT group (34.8 vs 39.5; p = 0.014). The PSM did not differ significantly between the NADT and non-NADT group (36.4% vs 43.9%; p = 0.131).

Table 4 Pathological Outcomes of Non-NADT and NADT

Subgroup analysis for perioperative and pathological outcomes of the non-low risk prostate cancer patients are presented in Table 5. The perioperative outcomes, which included operative time, EBL, blood transfusion rate and length of hospital stay, were significantly better in the NADT than in the non-NADT group. Only adjacent organ injury rate showed no significant difference in the two groups. The pathological stage was significantly different in the two groups (p < 0.001). The GS of the specimens was significantly higher in the NADT group (7.5 [79] vs 7 [78]; p < 0.001) and the specimen weight was significantly lower in the NADT group (35 [29.144] mL vs 40 [32.251.5] mL; p = 0.002). However, the PSM still did not show a significant difference between the NADT and non-NADT groups (43.6% vs 47.8%; p = 0.506).

Table 5 Perioperative Outcomes and Pathological Outcomes of PCa Non-Low Risk Group

Neoadjuvant therapy is the current standard of care for several solid tumour malignancies, including bladder, breast, and rectal cancer. NADT prior to surgery may downstage a malignancy to facilitate surgical resection, thereby lowering the positive surgical margin rate and improving perioperative outcomes.13,14 In our study, the median operative time was significantly lower in the NADT than in the non-NADT group (p=0.018) and a lower EBL was also observed in the NADT group (p<0.001).

Androgen deprivation therapy affects tumour behaviour and biology by changing the metabolic patterns of atrophy, lowering serum PSA level and reducing histopathologic atrophy.3 These tumour responses may have contributed to the smaller prostate volume in the NADT group than in the non-NADT group (39.5 vs 34.8 g, p = 0.014), since enlarged prostate glands usually have more vascularity and a wider resection margin.1517

The transfusion rate did not differ significantly between the two groups (p = 0.091). This may reflect the practice in our hospital of having the anaesthesiologist initiate transfusion when the haematocrit drops below 30. Consequently, some patients with a higher baseline haematocrit would be less likely to receive a transfusion.

The length of hospital stay also did not differ statistically between the two groups. However, the hospital stays were longer in the present study than in a previous study by Wallerstedt et al,18 who reported lengths of hospital stay of around 3.34.1 days. This discrepancy can be attributed to an institutional practice where patients are routinely discharged after the closed-suction pelvic drain is removed. However, many other factors, such as socioeconomic status, inexpensive room rates, anxiety and patient pain tolerance, might affect the length of a hospital stay.

No pathological down-staging could be demonstrated in the present study because of the limited pre-operative T clinical staging. In our setting, pre-operative imaging is not generally affordable for all patients, so many patients are classified as T1c (91.4%). Nevertheless, the data show a decrease in the median GS in the NADT group from the pre-operative biopsy specimen score of 879 to the post-operative specimen score of 7.79

The oncological control of RP in prostate cancer can be measured by the PSM, biochemical recurrence (BCR) rate, time to biochemical recurrence, local recurrence and distant metastasis.19 Sachdeva et al20 and other researchers2124 have shown that a PSM in prostate cancer is considered an adverse oncologic outcome and is associated with an increased likelihood of BCR. However, the significant predictors of BCR are tumour volume, a high GS and a high pre-operative PSA level. In our study series, no statistically significant difference was noted in PSM between both groups, which is consistent with the results of many guidelines and the current literature.2,4,5 The PSM rate in large series data ranged from 11% to 50%11 and from 12.1% to 41.3% in a recent meta-analysis.12 The PSM rate in our study was higher, which may reflect the participation of multiple surgeons in this study, as each surgeon may have had a different learning curve. For example, in the present study, two new instructor surgeons had just started performing RALRP in 2016. In addition, after the subgroup analysis, most of the PSMs were in the T3 stage, indicating that PSMs could result from the nature of the cancer that had extended beyond the prostatic capsule.

The subgroup analysis revealed that the perioperative and pathological outcomes significantly better almost all parameters in the non-low risk NADT group. This can be related to the fact that study was heterogenous and not weighted towards those who may benefit the most from NADT.

Patients with PSM are typically given two treatment options: external beam radiation therapy (proton beam radiation) with or without androgen deprivation therapy (ADT) or observation. Unfortunately, data related to the rate of conversion and catheterisation time could not be collected to determine our patient outcomes, as this study was retrospective. The functional outcomes, such as incontinence and erectile dysfunction, are presently being assembled by the authors, who will report on these findings in a subsequent study.

Author want to underline some interesting upcoming trend from the Pignot and Walz,25 and we comply with their findings that the multimodal approach including both local and systemic treatment neoadjuvant may be an option for selected patients especially with non-low risk prostate cancer. However, there is still not enough data to conclude when is the best setting for treatment (Neoadjuvant/adjuvant) and who would really benefit from treatment.

The present study has some limitations. One was its retrospective nature, which compared the effect of NADT with non-NADT but did not include data regarding the type of ADT, since no standard regimens for NADT currently exist. Consequently, the choice of treatment for each patient is highly heterogeneous and depends on patient insurance and physician preference. A second limitation is that all RPs were performed by different surgeons, raising the possibility of bias in the process of evaluating the procedure outcomes. A third limitation is that this study lacked data about the oncological and functional follow-ups. A fourth limitation is that this study had some significant differences in baseline characteristic, approach, PSA pre-op and GS from biopsy (33.4 [16.256.6] vs 10.1 [7.215.2]; p = <0.001 and 8 [79] vs 7 [67]; p = <0.001), as a result of the selection bias by physician typically offer treatment with NADT in high or very high-risk disease and the trend toward the Robotic-assisted era which can confound the effect of NADT. The findings of the present study would be strengthened by conducting a prospective randomised study with a higher case volume, as this would reduce biases and provide much more accurate results.

This study has demonstrated the long-term data on the use of NADT prior to RP and has shown an association between NADT and a positive effect on perioperative outcomes in the prostate cancer non-low risk group. Further randomized, prospective studies are needed to elucidate the true effect of NADT on perioperative outcomes, pathological outcomes and survival benefit.

This work was supported by Wijittra Matang, Yada Phengsalae and Kornkanok Somboonpun. The authors thank Wijittra Matang, Yada Phengsalae and Kornkanok Somboonpun for continued support and encouragement.

The authors declare no conflicts of interest in this work.

1. National cancer institute Doms, Thailand. Hospital base cancer registry 2015. 2017.

2. network NCC. Prostate cancer (Version 1.2020). Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed May 14, 2021.

3. Meng MV. Treatment of Locally Advance Prostate Cancer. 12th ed. Partin AW, editor. Elsevier; 2020:2.

4. Sanda MG, Chen RC, Crispino T, et al. Clinically localized prostate cancer: AUA/ASTRO/SUO guideline; 2017. Available from: https://www.auanet.org/guidelines/prostate-cancer-clinically-localized-guideline#x14226. Accessed May 14, 2021.

5. Mottet N, Bellmunt J, Briers E, et al. EAU ESTRO ESUR SIOG guidelines on prostate cancer; 2020. Available from: https://uroweb.org/guideline/prostate-cancer/. Accessed May 14, 2021.

6. Montgomery B, Tretiakova MS, Joshua AM, et al. Neoadjuvant enzalutamide prior to prostatectomy. Clin Cancer Res. 2017;23(9):21692176. doi:10.1158/1078-0432.CCR-16-1357

7. McKay RR, Montgomery B, Xie W, et al. Post prostatectomy outcomes of patients with high-risk prostate cancer treated with neoadjuvant androgen blockade. Prostate Cancer Prostatic Dis. 2018;21(3):364372. doi:10.1038/s41391-017-0009-6

8. Tosco L, Laenen A, Briganti A, et al. The survival impact of neoadjuvant hormonal therapy before radical prostatectomy for treatment of high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2017;20(4):407412. doi:10.1038/pcan.2017.29

9. Chen MC, Kilday PS, Elliott PA, et al. Neoadjuvant leuprolide therapy with radical prostatectomy: long-term effects on health-related quality of life. Eur Urol Focus. 2020. doi:10.1016/j.euf.2020.03.001

10. Meyer F, Bairati I, Bedard C, Lacombe L, Tetu B, Fradet Y. Duration of neoadjuvant androgen deprivation therapy before radical prostatectomy and disease-free survival in men with prostate cancer. Urology. 2001;58(2 Suppl 1):7177. doi:10.1016/S0090-4295(01)01245-6

11. Soloway MS, Pareek K, Sharifi R, et al. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002;167(1):112116. doi:10.1016/S0022-5347(05)65393-1

12. Silberstein JL, Eastham JA. Significance and management of positive surgical margins at the time of radical prostatectomy. Indian J Urol. 2014;30(4):423428. doi:10.4103/0970-1591.134240

13. Gmez Veiga F, Lorenzo Patio MJ, Daz Bermdez J, et al. [Effect of complete androgen block before radical prostatectomy for cancer of the prostate]. Arch Esp Urol. 1997;50(4):355363.

14. Polito M, Muzzonigro G, Minardi D, Montironi R. Effects of neoadjuvant androgen deprivation therapy on prostatic cancer. Eur Urol. 1996;30(Suppl 1):2631. doi:10.1159/000474242

15. Frota R, Turna B, Santos BM, Lin YC, Gill IS, Aron M. The effect of prostate weight on the outcomes of laparoscopic radical prostatectomy. BJU Int. 2008;101(5):589593. doi:10.1111/j.1464-410X.2007.07263.x

16. Hsu EI, Hong EK, Lepor H. Influence of body weight and prostate volume on intraoperative, perioperative, and postoperative outcomes after radical retropubic prostatectomy. Urology. 2003;61(3):601606. doi:10.1016/S0090-4295(02)02422-6

17. Kim MS, Jang WS, Chung DY, et al. Effect of prostate gland weight on the surgical and oncological outcomes of extraperitoneal robot-assisted radical prostatectomy. BMC Urol. 2019;19(1):1. doi:10.1186/s12894-018-0434-4

18. Wallerstedt A, Tyritzis SI, Thorsteinsdottir T, et al. Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy. Eur Urol. 2015;67(4):660670. doi:10.1016/j.eururo.2014.09.036

19. Akand M, Celik O, Avci E, Duman I, Erdogru T. Open, laparoscopic and robot-assisted laparoscopic radical prostatectomy: comparative analysis of operative and pathologic outcomes for three techniques with a single surgeons experience. Eur Rev Med Pharmacol Sci. 2015;19(4):525531.

20. Sachdeva A, Veeratterapillay R, Voysey A, et al. Positive surgical margins and biochemical recurrence following minimally-invasive radical prostatectomy an analysis of outcomes from a UK tertiary referral centre. BMC Urol. 2017;17. doi:10.1186/s12894-017-0262-y

21. De La Roca RL, Da Cunha IW, Bezerra SM, Da Fonseca FP. Radical prostatectomy and positive surgical margins: relationship with prostate cancer outcome. Int Braz J Urol. 2014;40(3):306315. doi:10.1590/S1677-5538.IBJU.2014.03.03

22. Meeks JJ, Eastham JA. Radical prostatectomy: positive surgical margins matter. Urol Oncol. 2013;31(7):974979. doi:10.1016/j.urolonc.2011.12.011

23. Pettenati C, Neuzillet Y, Radulescu C, Herve JM, Molinie V, Lebret T. Positive surgical margins after radical prostatectomy: what should we care about? World J Urol. 2015;33(12):19731978. doi:10.1007/s00345-015-1580-x

24. Yossepowitch O, Briganti A, Eastham JA, et al. Positive surgical margins after radical prostatectomy: a systematic review and contemporary update. Eur Urol. 2014;65(2):303313. doi:10.1016/j.eururo.2013.07.039

25. Pignot G, Walz J. Identifying the relevant population for neoadjuvant chemo-hormonal therapy combined with radical prostatectomy. Gland Surg. 2020;9(2):495497. doi:10.21037/gs.2019.12.22

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Neoadjuvant Androgen Deprivation Therapy Effects on Perioperative Outc | RRU - Dove Medical Press

Recommendation and review posted by Bethany Smith

Many have heard about the fire that caused $1 million dollars of damage to the very large residential home called Brigadoon Cottage on Mackinac Island on the evening of Sunday, May 30, 2021. What you may not have heard is the great news of the businesses and their staffs on Mackinac Island that came together to save a wedding reception.

A couple had gotten married that day and had just started their wedding reception next door to the Brigadoon Cottage at the Mackinac Island Yacht Club. MLive is reporting just after the guest were seated about a minute into the father-of-the-bride speech they noticed the fire.

What happened next is all good news and something you would see in a movie.

The Yacht Club staff called the Mission Point Resort staff and arranged for the wedding reception to be moved to their facility down the road. They used carriages, bikes and whatever else they could to move all of the necessary items from the Yacht Club to Mission Point.

We are told that within 30 minutes the reception was back on at Mission Point.

Many pitched in to help this couple on their wedding day. Even a local restaurant opened up their kitchen so the Yacht Club chefs could finish preparing the dinner for the guests. The article even states the staff from Mission point who was not working that day heard about what happened and came to help however they could.

The bride, Elizabeth Landuyt said they were very grateful and very blessed.

Her newly minted husband, Jake Landuyt put it this way:

We were blown awayTo see all our guests basically in the same spot as we had set up before. It was disbelief and overwhelming in the positive way. To go from that same state of disbelief to the exact opposite, were just so blessed to have friends and family there that were willing to do it.

Mission Points vice president of sales and marketing, Liz Ware said:

We love being a part of the amazing Mackinac Island community, where people and fellow businesses can come together to make magic happenOur entire team at Mission Point was proud to be a part and followed our brand pillars in delivering hospitality from the heart and to always do the right thing. Our core values include going the extra mile and working hard together with a great sense of Michigan pride, and we believe this is one of the reasons the Landuyts wedding reception was a truly celebratory occasion.

What a great story they will have to remember for the rest of their lives and what a great story to start our Friday and weekend off with.

Share the love and share this story.

The Live with Renk show airs Monday through Friday from 9 a.m. tonoon, to let me know your thoughts call (269) 441-9595

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Mackinac Island Businesses And Staff Save A Wedding Reception - wbckfm.com

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Genetic Testing Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

The genetic testing market is poised to grow by $5.39 billion during 2021-2025, progressing at a CAGR of about 12%.

The market is driven by the rising prevalence of genetic diseases and disorders, rising approval of advanced genetic testing products, and increasing affordability due to reduction in the cost of genetic testing.

The report on the genetic testing market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors. The report offers an up-to-date analysis regarding the current global market scenario, latest trends and drivers, and the overall market environment. The genetic testing market analysis includes product segment and geographic landscape.

This study identifies the advancements in next-generation sequencing as one of the prime reasons driving the genetic testing market growth during the next few years. Also, the growing adoption of direct-to-consumer genetic tests in early disease diagnosis and the growing adoption of pharmacogenetic testing in reducing adverse drug events will lead to sizable demand in the market.

The publisher's robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading genetic testing market vendors that include Abbott Laboratories, Agilent Technologies Inc., bioMerieux SA, Bio-Rad Laboratories Inc., F. Hoffmann-La Roche Ltd., Illumina Inc., Myriad Genetics Inc., QIAGEN NV, Quest Diagnostics Inc., and Thermo Fisher Scientific Inc.

Also, the genetic testing market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

Key Topics Covered:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Product

Segmentation by Application

Customer Landscape

Geographic Landscape

Vendor Landscape

Vendor Analysis

Appendix

For more information about this report visit https://www.researchandmarkets.com/r/pwg97i

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Global Genetic Testing (Equipment & Consumables) Market 2021-2025: Rising Approval of Advanced Genetic Testing Products and Increasing...

Recommendation and review posted by Bethany Smith

Researchers evaluated the clinical utility of genetic testing with MammaPrint 70-gene signature to determine how well this assay works in comparison with clinical assessment to determine the need for chemotherapy in women with breast cancer involving 0 to 3 lymph nodes. The phase 3 MINDACT findings, which included the survival outcomes of patients with an ultralow risk 70-gene signature, were presented during the 2021 American Society of Clinical Oncology Annual Meeting.

The 70-gene signature can identify patients with an ultralow risk of distant recurrence. These 1000 MINDACT patients had an excellent 8-year breast cancerspecific survival (BCSS) above 99%, regardless of clinical risk, and low rates of distant metastasis, explained Josephine Lopes Cardozo, MD, of the Netherlands Cancer Institute.

The median follow-up for disease assessment was 8.7 years. Of the 6693 patients enrolled in the study (ClinicalTrials.gov Identifier: NCT00433589), 1000 patients (15%) were identified as having an ultralow risk using 70-gene signature profiling and 67% of these patients were older than age 50. A majority of the patients were estrogen receptorpositive (99%), lymph nodenegative (80%), had grade 1 or 2 tumors (96%), and tumors below 2 cm in size (81%).

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Systemic therapy was administered in 83% of the study population; 69% of patients received endocrine therapy (ET), 14% received ET in combination with chemotherapy, and 16% did not receive adjuvant systemic therapy (AST). The trials primary endpoint was distant metastasis-free interval (DMFI).

At a median duration of 8 years, excellent DMFI and BCSS was observed in the low-risk and ultralow-risk group of patients. The 8-year DMFI for low-risk and ultralow-risk groups was 94.5% (95% CI, 93.6-95.3) and 97.0% (95% CI, 95.8-98.1), respectively. The 8-year DMFI in the ultralow-risk group who had not received AST was 97.8% (95% CI, 95.3-100). The 8-year DMFI in the ultralow-risk group who had received ET only was 97.4% (95% CI, 96.1-98.7). Based on the preliminary results after adjusting for tumor and treatment characteristics, DMFI for ultralow-risk vs low-risk groups had a hazard ratio (HR) 0.66 (95% CI, 0.46-0.95). The 8-year BCSS for genomic low-risk and ultralow-risk patients was 98.2% (95% CI, 97.7-98.7) and 99.6% (95% CI, 99.1-100), respectively.

We can confirm that the 70-gene signature can identify patients with ultralow risk of distant recurrence and these patients could be candidates for further de-escalation of treatment, further reducing overtreatment and the risk of side effects, concluded Dr Cordozo.

Disclosure: This research was supported by a grant from the EORTC Breast Group and the Netherlands Cancer Institute. Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors disclosures

Read more ofCancer Therapy Advisorscoverage of the 2021 ASCO Annual Meeting by visiting the conference page.

Reference

Cardozo JL, Drukker C, Schmidt M, et al. Outcome of patients with an ultralow risk 70-gene signature in the MINDACT trial. J Clin Oncol. 2021;39:(suppl 15; abstr 500). doi:10.1200/JCO.2021.39.15_suppl.500

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MammaPrint 70-Gene Signature Identifies Ultralow-Risk Patients With Outstanding Prognosis in Breast Cancer - Cancer Therapy Advisor

Recommendation and review posted by Bethany Smith

A medicine from AstraZeneca and Merck & Co. has become the first of its type to slow the return of a particularly aggressive, hereditary form of breast cancer, a significant finding that may push doctors to do more genetic testing in patients with the disease.

The results, from a 1,836-patient study of a drug called Lynparza, are being presented at the American Society of Oncology's virtual meeting Sunday and were published Thursday in the New England Journal of Medicine. They've been anticipated ever since AstraZeneca and Merck in February surprisingly said the Phase 3 study succeeded, without giving details. They could help change care for patients with an inherited gene mutation associated with roughly 5% of all breast cancers.

"These results will transform the prognosis, overnight, for [these] patients," said Chatrick Paul, the head of AstraZeneca's U.S. oncology division.

Patients in the so-called OlympiA trial received either Lynparza or placebo for a year of "adjuvant" treatment, meaning after surgery to remove a tumor and standard drugs such as radiation, chemotherapy or hormone therapy. All participants inherited a mutation to a gene, BRCA1 or BRCA2, and were considered at high risk of cancer recurrence because of the size of their tumor or other factors. Their tumors were either HR-positive or triple-negative, two of the three main forms of breast cancer.

Among these patients, researchers found Lynparza reduced the risk of disease progression or death by 42% compared to a placebo after a median of 2.5 years of follow-up. About 86% of Lynparza-treated patients were cancer-free, versus 77% of those who got a placebo.

Patients on Lynparza also had a 43% lower risk of developing or dying from more lethal "distant" tumors that appear elsewhere.

Those numbers are "clinically meaningful and practice changing," said Sayeh Lavasani, an assistant clinical professor at City of Hope's Department of Medical Oncology & Therapeutics Research. Lavasani wasn't involved in the trial.

Follow-up is still limited, however, meaning it's unclear how long a year of Lynparza treatment will extend patients' lives data that Paul acknowledges is a "critical piece" of missing information.

The drug is "no walk in the park," added Debu Tripathy, the chair of MD Anderson Cancer Center's breast medical oncology department, referring to side effects like nausea, vomiting and diarrhea. In rarer cases, treatment was associated with severe anemia that can require a blood transfusion.

The authors of the study also admit they don't know how Lynparza compares to a type of chemotherapy, Xeloda, that has been proven an effective adjuvant treatment for some breast cancer patients.

Nonetheless, "this is a big win," said Tripathy, who also wasn't involved in the trial. Assuming approval from regulators, "patients with higher-risk cancers who have BRCA mutations will now be getting this."

The drugmakers aim to get the results in the hands of regulators "as quickly as possible," said Roy Baynes, Merck's senior vice president of global clinical development.

Breast cancer remains the most commonly diagnosed cancer as well as the second-leading cause of cancer death among women, despite substantial advances in treatment over the past few decades. The death rate associated with the disease declined 40% between 1989 and 2017, according to the American Cancer Society. Better early cancer detection is a big reason why.

A majority of early breast cancer patients are now cured of their disease, according to Tripathy. But about a third relapse. When they do, their cancers become much more deadly. In response, researchers have sought to bring new drugs like immunotherapies and other therapies known as CDK 4/6 inhibitors that have been approved in advanced disease into earlier settings, when they might stop cancers from returning.

Broadening use of these types of drugs comes with trade-offs, though. If cleared to lower the risk of recurrence, high-priced cancer drugs would likely become more widespread, raising costs for uninsured patients and, potentially, insurance premiums for others, Tripathy said. Insurers can block access as well; Lavasani is "hoping" they will cover Lynparza, should it be approved as an adjuvant treatment. Often, the drugs are approved on the likelihood, but not the certainty, that they'll help people live longer.

Clinicians and regulators also have to decide whether the benefits are worth added side effects for patients who tend to be younger and healthier. The FDA, for instance, asked Merck for more data when it rejected its immunotherapy Keytruda in early triple-negative breast cancer. An advisory panel was wary of the side effects associated with treatment, which Tripathy noted, can include permanent liver or kidney injury. (Merck has since gathered more data and intends to re-file for approval.)

Lynparza had what Lavasani, of City of Hope, called "acceptable toxicities," most frequently nausea and fatigue. Consistent with what's been reported in earlier testing, the only severe side effect seen in more than 5% of patients was anemia, which occurred in 79, or about 9%, of those who got Lynparza.

Those side effects were balanced against Lynparza's benefit in slowing breast cancer's return in patients who had inherited mutations to the BRCA1 or BRCA2 genes. These patients tend to develop cancers at a younger age, have faster-moving disease and a much higher risk of relapse, some studies have shown. OlympiA study authors noted, for instance, that almost one-quarter of patients on placebo with HR-positive cancer a typically slow-moving tumor had invasive disease or died within three years.

There were no marketed drugs specifically tailored to BRCA1 and BRCA2 breast cancers for patients with metastatic disease until the FDA approved Lynparza and Talzenna, another, similar PARP inhibitor from Pfizer, in 2018. Those approvals came amid early enthusiasm for PARP inhibitors, which are mainly used as "maintenance" therapies in ovarian cancer.

Testing for BRCA mutations, as a result, has lagged for those with early-stage disease: 60% to 70% of patients with triple-negative tumors, and 25% to 35% of HR-positive patients are being tested, according to Ipsos Healthcare's Global Oncology Monitor.

"It's not where it should be," says Paul, of AstraZeneca.

The OlympiA results, then, could change testing practice. The data are a "call to action" to make sure patients know their BRCA status, said Merck executive Baynes.

Oncologists, Tripathy added, may push to broaden testing guidelines for patients beyond those who get cancer at a young age or have a family history of BRCA mutations.

"We would like to get to a point someday when we take the risk totally away, that having breast cancer is no longer something that can lead to fatality," Tripathy said. "We got a little closer to that with this trial."

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An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up? - BioPharma Dive

Recommendation and review posted by Bethany Smith

Eight years later Adam, now 21 and a gymnastics coach, would have high blood pressure and experience a carotid artery blowout. Thankfully, though, his neck muscles saved his life.

The teeth abnormalities, as well as the carotid artery blowout, are likely due to the calcification in the body that patients with this illness can present, said Prasov. With the genetic testing, we were able to conclude this disease was Singleton-Merten syndrome type II an extremely rare, autosomal, dominant condition with only 3 families documented in literature.

With their collective expertise, the team was able to better characterize the familys symptoms: pediatric-onset glaucoma, spontaneous tendon rupture, arthritis, and a psoriasis-looking skin rash. Glaucoma and skin rash were the most prominent symptoms.

There werent many cases in literature to compare the familys disease presentation to, so Prasov, whose research focuses on inherited eye diseases, worked with colleagues at the National Institutes of Health and U-M clinician-scientists Johann Gudjonsson, M.D., Ph.D., a dermatologist, and J. Michelle Kahlenberg, M.D., Ph.D., a rheumatologist, to more deeply phenotype the family.

When looking for new genes, it can take a considerable amount of time. Once we could perform sequencing, we could move a lot faster to get a diagnosis. The Gibson family had an official diagnosis approximately a year after we performed the sequencing. said Prasov.

He adds that working in the field of genetics comes with certain challenges; the provider making the diagnosis wants to be absolutely certain that the genetic change is causing the disease, as it can have a big impact on clinical management.

More certainty came with the identification of another family across the globe in Belm, Brazil, that had a similar peculiar set of clinical findings and the same genetic variant in DDX58. By comparing notes among all of the identified families, Prasov and his team were able to give a definitive diagnosis.

But the final piece of this medical puzzle required additional work in the laboratory.

According to Prasov, very few families with mutations in DDX58 have a multi-system disorder featuring calcification in the body, skin rashes and childhood glaucoma.

Published in the Journal of Medical Genetics, Prasov led an international team, including researchers and clinicians from U-M, the NIH, Brazil, and Harvard, to provide the first complete molecular and histological assessment of the eye and skin findings in Singleton-Merten syndrome type II. Together, they definitively showed that the familys mutation behaves similarly to other mutant proteins in how it sets off an inflammatory cascade in the body in absence of a definitive RNA trigger.

Because of the communication between these doctors, more of this condition is now better understood, said Eryn. Their curiosity led to answers, but also helped us feel like we were finally being heard and cared about. Finally, after generations of unanswered questions and enormous health challenges someone took this seriously and had access to the resources to find answers about this condition.

Since skin is the most available tissue for molecular analysis, Gudjonsson and his team were able to obtain samples from Stan and Adam to compare Stans gene expression to his children. Somewhat surprisingly, they found that the inflammatory response was only active in affected skin, and not in neighboring skin or in the blood.

The study team also found that the family in Brazil had a more severe case of Singleton-Merten syndrome. By working with the Brazilian clinicians and researchers, Prasov was able to compare data and see if other genetic triggers or environmental influences affect the presentation of the disease.

This is something I want to explore more, he said. Rachel and Adam dont have many of the system effects of this disease, but they could develop them in the future. Understanding all the factors that may provoke more severe illness may help us be able to prevent those developments from occurring.

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The study reinforces the idea that genetic triggers or environmental influences may affect the presentation of Singleton-Merten syndrome, as the research team found that some family members carrying the mutation only have the most common feature of childhood glaucoma, while others have more extensive disease features that affect the immune system.

This means there could be other children in the world with this glaucoma that dont have the other features of the disease, said Prasov. But theyre at risk for developing those features later in life and suffer serious health consequences if providers dont know to look out for all these symptoms.

There are drugs like Rinvoq, a medication that Stan now takes, that can help calm the immune system and disrupt the downstream pathway associated with more serious disease. According to Stan, the medication has helped his skin discoloration resolve.

Im so grateful to know what this condition is. Knowing how to treat it would be a miracle, but you have to start somewhere, said Stan. This research will benefit my own children but also their children when they start families of their own. They know what to look out for.

This study highlights how a genetic diagnosis can have a big impact on clinical practice and patient outcomes, said Prasov. Understanding this disease pathogenesis is also important in the field of glaucoma care and research. Prasov now leads a multidisciplinary clinic in which he partners with pediatric medical geneticists to provide ophthalmic genetic care for families like the Gibsons.

The next step for the U-M research team is to generate an animal model to better understand the disease and hopefully find a targeted drug treatment that may have fewer side effects. They also plan to further study the role of DDX58 in the eye, since the RNA binding protein can sense viral infections like Rubella and Zika: viruses known to provoke glaucoma. The hope is that they can find a way to block this receptor or the downstream signaling, in turn preventing the glaucoma from developing.

Stan has a severe case of Singleton-Merten so my hope is that if researchers can crack his case, they can know how to treat anyone with the condition, said Eryn. If it wasnt for Kellogg Eye Center, both of my kids would be blind. Im just grateful beyond words.

This research was supported by the National Eye Institute (NEI K12 EY022299, NEI P30 EY07003, RBH, BG, and BPB), the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health (R01-AR060802, P30-AR075043 and K01-AR072129), the National Institute of Allergy and Infectious Diseases (R01-AR069071), the A. Alfred Taubman Medical Research Institute, the Parfet Emerging Scholar Award and the Roche Postdoctoral Fellowship.

Paper cited: DDX58(RIG-I)-related disease is associated with tissue-specific interferon pathway activation, Journal of Medical Genetics. DOI: 10.1136/jmedgenet-2020-10744

Originally posted here:
Family finds answers to rare, genetic glaucoma - University of Michigan Health System News

Recommendation and review posted by Bethany Smith

It is understood that while genes are the bodys blueprint its basic physical and functional unit of heredity not a lot of people pause to think about genetic anomalies or disorders that may be affecting their health.

Women, especially, are unaware of just how much their genes impact their health, and how prevention of certain genetic diseases can be done to ensure a healthy offspring.

Dr Hema Purandarey, consultant medical and reproductive geneticist, MedGenome Centre for Genetic Health Care shares with indianexpress.com some health conditions that women are more prone to through genetics, and the tests available to detect them.

1. Chromosomal aneuploidy in babies of expecting mothers: A condition in which a cell has an incorrect number of chromosomes. If there is an error in the normal processes of fertilization, there can be changes to the number or structures of chromosomes which can lead to an offspring with birth defects due to the abnormal structure or number.

The most commonly seen type of defect is an extra chromosome 21 called trisomy 21 or Down syndrome. Genetic screening and diagnostic tests are available with pre-test and post-test counselling which can identify these changes in the foetal state. These include specific noninvasive screening tests like NIPT and parental karyotypes and invasive diagnostic tests such as amniocentesis and chorionic villus sampling to identify the genetic makeup of the baby.

2. X-linked inherited disorders: Some disorders are X-linked, which means a female with 2X chromosomes will be a carrier, but if she passes this to her male offspring, it will be affected since males only inherit one X chromosome from their mother, the other being a Y chromosome inherited from the father. Finding out about carrier status prior to conception can help to plan genetic counselling. Testing is available for several such disorders like Fragile X, Hemophilia, Duchenne Muscular Dystrophy etc.

3. Hematological disorder screening: Couples have to be screened if they are carriers for common hematological disorders such as thalassemia and sickle cell disease. Consanguinity increases the risk of having any recessive genetic disorder by approximately 25 per cent.

A carrier screening test can help prevent both X-linked and conditions such as thalassemia and sickle cell anemia from being passed on. It also helps couples understand and plan better for their future. This is a comprehensive test screening, with the capability to detect mutations causing disease in more than 2,000 genes.

4. Recurrent pregnancy loss: Three or more consecutive pregnancy losses before 20 weeks from the last menstrual period are defined as recurrent pregnancy loss or RPL. Epidemiological studies show 1 per cent to 2 per cent of pregnant women suffer from RPL. Genetic causes of recurrent pregnancy losses account for about 2-5 per cent. Chromosomal or genetic abnormalities lead to most losses of pregnancy. The abnormality might come from the early embryo, egg, or sperm.

There are genetic tests that can help detect if the pregnancy loss was due to an abnormal number of chromosomes, and provide insights to plan and support a successful pregnancy in future.

5. Implantation failure during IVF: One in two human preimplantation-IVF embryos are chromosomally abnormal. This causes them to implant onto the uterine wall or not stay there long enough for a successful pregnancy. This leads to miscarriages and failed IVFs. If there is a family history of a genetic disorder, the fertilized embryo can be tested using pre-implantation genetic testing. If a donor was used, the donor sperm or the egg can be tested.

6. Hereditary breast and ovarian cancer: In women, approximately 15 per cent of all ovarian cancers and 7 per cent of all breast cancers are caused by mutations in the BRCA1 and BRCA2 genes. At present, we have predictive tests like BRCA1 and BRCA2 gene tests for this. Actor Angelina Jolie had a history of breast and ovarian cancer. So, she asked to be genetically tested and when it was clear she was susceptible, she had the required surgeries. Early detection can not only save life but also reduce the financial burden of advanced treatment.

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Genetic health conditions every woman should know about - The Indian Express

Recommendation and review posted by Bethany Smith

CHICAGO, June 4, 2021 /PRNewswire/ -- According to the new market research report "Animal Genetics Market by Products & Services (Live Animals (Poultry, Porcine, Bovine, Canine) Genetic Material (Semen (Bovine, Porcine), Embryo (Bovine, Equine)) Genetic Testing (DNA Testing, DNA Typing, Genetic Traits Testing)) - Global Forecast to 2026", published by MarketsandMarkets, the global market is projected to reach USD 7.7 billion by 2026 from USD 5.5 billion in 2021, at a CAGR of 7.1% during the forecast period.

Browse in-depth TOC on "Animal Genetics Market"

269 Tables 36 Figures 296 Pages

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The growth of this market is majorly attributed to the increasing consumption of animal-derived protein, growing global population & rapid urbanization, growing focus on identifying superior breeds, increased adoption of genetic services to prevent genetic diseases & business loss, and increased adoption of advanced genetic technologies. On the other hand, the shortage of skilled professionals in veterinary research is a key factor restraining market growth.

By product type segment, the live animals segment accounted for the largest market share during the forecast period.

Based on products and services, the animal genetics market has been segmented into live animals, genetics materials, and animal genetic testing services. The factors attributing to the large revenue of the live animals segment include high demand for live animals for breeding purposes. The introduction of disease-resistant animals has further boosted the demand for live animals, as they are economically viable for owners and increase their profitability.

Poultry accounted for the largest animal genetics marketshare in the live animals segment during the forecast period.

In the live animals segment, poultry accounted for the largest market share during the forecast period. This can be attributed to the strong demand for poultry and eggs in developed countries. Additionally, due to the growing population and rapid urbanization in developed countries, the demand coming from these regions is also increasing significantly.

In the segment of the genetic material, semen accounted for the largest market share during the forecast period.

Under the segment of the genetic material, semen held the largest share, most of which came from bovine semen during the forecast period. Growth in this market is mainly driven by the increasing need for raising highly productive animals to meet the growing demand for meat and other animal-derived products.

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Europe dominates the Animal Genetics market during the forecast period.

Europe accounted for the largest share of the market in 2020. Better accessibility to technologies and well-established distribution channels, the growing demand for livestock food products, high intake of animal-derived proteins, and increasing animal welfare activities are the major factor contributing to this.

The major players in the global animal genetics market include Neogen Corporation (US), Genus (UK), URUS (US), EW Group (Germany), Groupe Grimaud (France), CRV Holding (Netherlands), Topigs Norsvin (Netherlands), Zoetis (US), Envigo (US), Hendix Genetics (Netherlands), Animal Genetics (US), VetGen (US), DanBred (Denmark), Tropical Bovine Genetics (India), Trans Ova Genetics (US), Inguran LLC dba ST Genetics (US), Semex Alliance (Canada), Genetic Veterinary Sciences (US), Cobb-Vantress (US), Milk Source (US), and Eurogene AI Services (Ireland).

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Animal Genetics Market worth $7.7 billion by 2026 - Exclusive Report by MarketsandMarkets - PRNewswire

Recommendation and review posted by Bethany Smith

Top row, left to right: Steve Nelson, 4-year survivor; Anne Shimabukuro, 15-year survivor; Roberta Luna, 19-year survivor Bottom row, left to right: Teona Ducre, 5-year survivor; Cathy Schwandt, 8-year survivor; Nick Pifani, 4-year survivor

Editors note: In honor of National Cancer Survivors Day on June 6, 2021, we invited members of PanCANs Survivor Council to pass along encouraging words to pancreatic cancer patients and to also share what it means to them to be a survivor. The Survivor Council is a group of volunteers created to ensure the survivors voice, experience and expertise are integrated into PanCANs programs and initiatives. Today and every day, we honor all survivors and remember those whove lost their life to the disease. We are here for everyone affected by pancreatic cancer.

PanCAN: Celebrating life is one of the themes of National Cancer Survivors Day. How do you celebrate life?

Teona Ducre: I do my best to practice gratitude every day.Since surviving cancer, I understand that even the little things I may have taken for granted before seeing my children smile, hanging out with friends and family on a random Tuesday afternoon, or just waking up in the morning are really big blessings.

Roberta Luna: I celebrate life by savoring every moment, not taking anyone or anything for granted, trying to be the best person I can.Stop and smell the flowers, dance like nobodys watching, sing like no one is listening! I know these are all clich but when youve been given what seems like a death sentence, the little things really take on new meaning.

Steve Nelson: I celebrate every time I find an opportunity to tell my story of hope.

Nick Pifani: I celebrate life by making memories with the people I love and making a difference for a better tomorrow. I share my story with newly diagnosed patients with the goal of giving them hope.

Anne Shimabukuro: I value my time more. My priorities have shifted my family and my health come first. I am more willing to say no than I was before.

PanCAN: Have you started any new traditions since your cancer diagnosis?

Roberta: On April 9, 2013, a group of survivors, family and friends and I celebrated life by jumping out of an airplane. What we thought was a one-time event has turned into an annual tradition. Every April, for eight years and counting, a group of us skydive from a height of 14,000 feet. Theres always at least one first-time jumper with us.

Nick: Every year we celebrate my Whipple surgery anniversary. I was fortunate to come out of surgery cancer-free and I consider it a second birthday because I got a second chance at life.

PanCAN: What is your advice for people living with pancreatic cancer or for those who are newly diagnosed?

Roberta: My advice to someone newly diagnosed is to get all the information, but dont let it weigh you down. Ask questions, be your own advocate, remember to enjoy life and keep fighting.

Steve: Never give up hope! I have a brother who is a 17-year survivor.And as a member of PanCANs Survivor Council, I know many others who have beaten the odds, and those odds get better every year.You could be next!

Nick: Remember that you are not a number and you dont fall into a specific category or statistic. If youve been recently diagnosed, contact PanCANs Patient Services and get genetic testing.

Anne: If youre living with pancreatic cancer, keep living! Do what you love. And give yourself a break. If youve been recently diagnosed, dont think about thestatistics. Your case is unique and its the only case you should care about. Put yourself first. And dont be afraid to ask for help.

PanCAN: What does it mean to you to be a survivor?

Teona: It means I can accomplish anything. Whenever I am faced with a challenge, I think, This is nothing. You survived one of the deadliest cancers in the world so you can do this, too. I also get the privilege to share my story to encourage others and that means a lot to me.

Roberta: To be a survivor means Ive been given a very special precious gift, the gift of life, the gift to love more deeply, the gift to inspire someone, to make a difference, to give back, to do better.

Steve: Due to genetic testing and a regular screening regimen, my cancer was discovered early. I encourage anyone with first or second-degree relatives who have or have had pancreatic cancer to get tested for genetic mutations. And if they find they have a mutation, to embrace regular screenings. It could save their life, like it did mine!

Nick: My story is different because I lost three family members to the disease I am the lone survivor. As a survivor, I carry a piece of my lost family members with me it inspires me to make a difference in this fight. This is how I honor them and make sure their cancer battle is never forgotten.

Cathy: We, the survivors, need to be the voice for all those who are no longer here.

Anne: As a 15-plus-year survivor, my survivorship is not always top of mind its now a part of me. This journey has given me strength as well as more self-confidence. Ill often remind myself, I conquered pancreatic cancer; I can deal with anything.

Read the original here:
Long-time pancreatic cancer survivors offer inspiration and advice - Pancreatic Cancer News & Stories

Recommendation and review posted by Bethany Smith

The role genetics play in atrial fibrillation (AF) complications such as heart failure and stroke will be investigated as part of new research involving UNSW researchers.

Led by Victor Chang Cardiac Research Institutes scientist and UNSW Conjoint Professor Diane Fatkin, the multicentre research team were awarded $1 million by The Heart Foundation to gain new knowledge about genetic causes of AF.

The condition is a major public health problem with one in three individuals at risk of developing it in their lifetime.

Prof. Fatkin said the research being done by her team is breaking fresh ground, and further advancement would not be possible without the recent financial boost.

This will really allow us to do in-depth genetic analyses on our patients, and we already have a large cohort of [those] available. This will enable us to do these genetic analyses for the first time in Australia, so it really is a major new initiative, she said.

We will use cutting-edge tools for rapid low-cost genetic analyses of AF patient cohorts that will enable us, for the first time, to look at single-gene mutations, genetic risk scores, and genetic effects on anti-arrhythmic drug metabolism. The cost and outcomes of genetic testing, and patient preferences for testing, will also be assessed.

AF is a disorder of the hearts electrical activity that can lead to stroke, heart failure and even early death.

A persons genetic make-up is an important determinant of AF susceptibility, but genetic information is not part of current patient care.

Scientists at the Victor Chang Cardiac Research Institute and UNSW would like that to change.

Prof. Fatkin said those facing choices about their treatment may really benefit from knowledge about genetic influences when selecting appropriate drug therapies or interventions, such as ablation therapy.

Genetics, we are thinking, may also be important for predicting the risk of recurrence of atrial fibrillation after the ablation procedures, she said.

Our data will define high-risk patient subsets and have direct implications for the screening and clinical management of family members.

Prof. Fatkin is looking at different types of patients across the research. Some have a family history of AF and the collated data will help identify family members also at risk of developing AF in the future.

Another group that is part of the research includes those without a clear family history of AF but who still have the condition.

A third group being studied is athletes who have developed AF after a lifetime of competitive sporting activity.

Prof. Fatkin hopes this research will lead to the ability to predict which athletes are likely to have heart problems in the future.

This may inform sports choices even in young kids, and we can advise those who are at high genetic risk to potentially change the type of sport that they participate in, she said.

The Heart Foundations Strategic Grants are awarded with the aim to generate innovative and collaborative research projects in the areas where identified gaps in cardiovascular health exist.

The 2020 Predictive Modelling Grant was awarded to Prof. Fatkin to investigate the role of genetics for risk stratification in AF.

See the original post here:
Genetic links to be investigated in ground-breaking heart rhythm research - UNSW Newsroom

Recommendation and review posted by Bethany Smith

The GlobalGenetic TestingMarket Research Report 2021-2028 is a valuable source of insightful data for business strategists. It provides the industry overview with growth analysis and historical & futuristic cost, revenue, demand and supply data. The research analysts provide an elaborate description of the value chain and its distributor analysis. This Market study provides comprehensive data which enhances the understanding, scope and application of this report. The Global Genetic Testing Market Report enfolds a comprehensive analysis and assessment of the global Genetic Testing market. The report mainly intends to help market players and clients to understand the market in terms of structure, scope, profitability, attractiveness, and growth possibilities. The report also highlights a detailed review of market segmentation, potentials, emerging trends, and volatilities in the global Genetic Testing market. Global Genetic Testing Market Report 2021 report records detailed estimation to improve complete information of the global Genetic Testing market today and its industrial outlook based completely on the current and purpose marketplace.

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Global Genetic Testing Market by Type:Newborn Screening, Diagnostic Testing, Carrier Testing, Preimplantation Genetic Diagnosis, Prenatal Diagnosis, Predictive and Presymptomatic Testing, Pharmacogenomics

Global Genetic Testing market segments by Applications:Cardiology, Dermatology, Hematology, Hereditary Cancer, Immunology, Metabolic Disorders and Newborn Screening, Neurology, Ophthalmology, Pediatric Genetics, Others

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Global Genetic Testing Market Trends, Forecast and Competitive Analysis (2021-2028) | GeneDx,Invitae,Pathway Genomics The Manomet Current - The...

Recommendation and review posted by Bethany Smith

In the second part of our whats exciting the experts series, Medical News Today spoke with another group of cancer experts. We asked them what recent advances have given them the most hope. Here, we provide a sneak peek at the fascinating forefront of cancer research in 2021.

Cancer is not a single disease but a collection of diseases. It is complex and does not readily give up its secrets. Despite the challenges cancer poses, scientists and clinicians continue to hone the way in which they diagnose and treat it.

Modern medicine means that diagnosis rates for many cancers are up, as are survival rates. However, with an estimated 19.3 million new cases of cancer worldwide in 2020, there is still much work to be done.

MNT recently contacted a number of medical experts and researchers and asked them to speak about the aspects of cancer research that they find most exciting. Their answers are fascinating and demonstrate the incredible variety of approaches that scientists are using to understand and combat cancer.

We will start todays journey into cutting edge oncology with a surprising guest: magnetically responsive bacteria.

Due to the difficulty of targeting systemically delivered therapeutics for cancer, interest has grown in exploiting biological agents to enhance tumor accumulation, explained Prof. Simone Schrle-Finke, Ph.D., from ETH Zurich in Switzerland.

In other words, getting cancer drugs to the right place is not as straightforward as one might hope. Prof. Schrle-Finke is among the researchers who are now enlisting the help of specialized bacteria.

She told MNT how scientists have known for a century that certain bacteria can colonize tumors and trigger regression. She explained that today, thanks to modern genetic engineering techniques, attenuated bacteria are available that can have a therapeutic effect exactly where this is necessary.

These therapeutic effects include secretion of toxins, competition for nutrients, and modulation of immune responses.

However, despite the promise of bacterial cancer therapy, there are still challenges to meet. Delivering the doses to the right place and getting them into the tumor remain foremost among challenges hampering clinical translation only about 1% of a systemically injected dose reaches the tumor, explained Prof. Schrle-Finke.

To address these challenges, her team at ETH Zurich is using magnetically responsive bacteria.

These so-called magnetotactic bacteria naturally orient themselves like compass needles to Earths magnetic field.

Although this ability evolved for navigation, scientists are keen to find out whether magnetic steering or pulling could allow them to repurpose it for cancer delivery.

In a recent study, Prof. Schrle-Finke and her colleagues used rotating magnetic fields to override the bacterias natural propulsion. As the authors of the study explain, they used swarms of magnetotactic bacteria to create a directable living ferrofluid.

These magnetotactic bacteria have a high demand for iron, so once they reach the tumor, as Prof. Schrle-Finke told MNT, they can metabolically influence cancer cells through starvation from this vital nutrient. We have shown in in vitro models that an increasing number of bacteria induce an upregulation of iron-scavenging receptors and death in cancer cells.

By uniting engineering principles and synthetic biology, we aim to provide a new framework for bacterial cancer therapy that addresses a major remaining hurdle by improving the efficiency of bacterial delivery using safe and scalable magnetic stimuli to these promising living therapeutic platforms.

Prof. Simone Schrle-Finke, Ph.D.

Personalized medicine is transforming the landscape of medicine and how healthcare providers can offer and plan personalized care for each of their patients, believes Dr. Santosh Kesari, Ph.D., director of neuro-oncology at Providence Saint Johns Health Center in Santa Monica, CA.

Dr. Kesari is also chair of the Department of Translational Neurosciences at Saint Johns Cancer Institute and regional medical director for the Research Clinical Institute of Providence Southern California.

Describing personalized medicine, Dr. Kesari said, It is an approach for disease prevention and treatment that takes into account biological, genetic, behavioral, environmental, and social risk factors that are unique to every individual.

He continued, Personalized medicine is rooted in early detection and prevention; integrating data from genomics and other advanced technologies; digital health monitoring; and incorporating the latest medical innovations for optimizing outcomes.

This is becoming very apparent in oncology, where genetic testing for tumor mutations and predispositions is increasingly being utilized and showing more value in using targeted drugs more wisely and improving outcomes.

Dr. Santosh Kesari, Ph.D.

Some personalized cancer approaches are already in use, such as EGFR, HER2, and NTRK inhibitors and the super personalized CAR-T cells.

According to Dr. Kesari, the future of personalization is bright, and progress has only accelerated in the past 5 years.

Continuing with the personalization theme, Dr. Robert Dallmann from Warwick Medical School at Warwick University in the United Kingdom talked with us about chronotherapy:

Propelled by the 2017 Nobel Prize in Medicine or Physiology [going] to three circadian biologists for uncovering the molecular mechanism of circadian biological clocks, cancer chronotherapy is gaining critical momentum to enter mainstream oncology especially in the context of personalized medicine.

Dr. Dallmann explained that many key physiological processes in the cells of our body are modulated in a daily fashion by the circadian clock. These cellular clocks are disrupted in some tumors but not in others.

Interestingly, a functional clock in the tumor predicts the survival time of patients, which has been shown for brain as well as breast tumors.

Therefore, he explained, if scientists could determine the clock status in solid tumors, it would allow doctors to more easily determine whether a patient is at high or low risk. It might also help guide therapy.

There is great potential in optimizing treatment plans with existing drugs by taking into account the interaction with the circadian system of the patient, continued Dr. Dallmann.

More recently, the circadian clock mechanism itself has been proposed as a novel treatment target in glioblastoma. The authors of the glioblastoma study concluded that pharmacologic targeting of circadian networks specifically disrupted cancer stem cell growth and self-renewal.

However, whether this might be generalized to many solid tumors or even other chronic diseases remains to be elucidated, said Dr. Dallmann.

In summary, he told MNT, circadian clocks have long been recognized to modulate chronic disease on many levels. The increased mechanistic understanding has the potential to improve diagnosis and existing treatments of cancer, as well as develop a new class of clock-targeting treatments.

Dr. Chung-Han Lee is a medical oncologist at Memorial Sloan Kettering Cancer Center in New York. He is also a member of the Kidney Cancer Associations Medical Steering Committee. He talked us through recent advances in the treatment of kidney cancer.

The development and subsequent regulatory approval of combination immunotherapy for patients with metastatic kidney cancer have led to transformative change in the lives of many patients and are the hallmark of how greater scientific understanding has impacted cancer care, Dr. Lee told MNT.

Prior to 2005, treatment for metastatic kidney cancer was very limited, with most patients passing away in less than 1 year despite undergoing treatment. According to Dr. Lee, the development of antiangiogenic drugs that inhibit the growth of new blood vessels was among the first breakthroughs to improve the outcomes for patients.

However, even with antiangiogenic drugs, most patients ultimately developed resistance to treatment, and 18 months was considered a long-term response. Next came immunotherapies.

Prior to the development of antiangiogenic medications, it was known that kidney cancer could be treated by activating the immune system to better recognize the disease. However, the tools to activate the immune system were often very nonspecific. Therefore, responses to these early immunotherapies were rare, and the side effects related to treatment were not only burdensome but also could be life threatening.

With recent advances in immunotherapy, we have demonstrated that more targeted immunotherapies that activate specific immune checkpoints are not only possible but can have substantially increased activity against disease.

Two emerging treatment approaches have now become the new standard of care for kidney cancer: dual immunotherapies (such as ipilimumab/nivolumab) or combinations of antiangiogenic targeted therapies with immunotherapies (such as axitinib/pembrolizumab).

In patients treated with ipilimumab and nivolumab, over 50% remain alive at 4 years, and with some [combined antiangiogenic and immunotherapy approaches], nearly 50% of patients remain on their initial therapy at 2 years.

Despite these advances, Dr. Lee is far from complacent, telling us that there remains considerable work to be done. [] Unfortunately, in 2021, for most patients, kidney cancer remains fatal. Even for those who have outstanding responses to treatment, most still require ongoing systemic therapy.

With the rapid improvements in treatments, the development of correlative biomarkers, and the improved biologic understanding of the disease, we have only started to entertain the possibility of curative, time-limited therapy.

Building on the sacrifices of patients and caregivers and the hard work of clinicians, research staff, and scientists, a cure may, one day, be a reality for our patients, he concluded.

Our study from late 2020 has shown that the antidepressant sertraline helps to inhibit the growth of cancer cells in mice, Prof. Kim De Keersmaecker from KU LEUVEN in Belgium told MNT.

Other studies had already indicated that the commonly used antidepressant has anticancer activity, but there was no explanation for the cause of this. Weve been able to demonstrate that sertraline inhibits the production of serine and glycine, causing decreased growth of cancer cells.

Cancer cells and healthy cells are often reliant on the amino acids serine and glycine, which they extract from their environment. However, certain cancer cells produce serine and glycine within the cell. They can become addicted to this production.

This internal production of serine and glycine requires certain enzymes, and these enzymes have become targets for cancer researchers. Preventing them from functioning can starve the cancer cells.

Previous studies have identified inhibitors of serine/glycine synthesis enzymes, but none have reached the clinical trial stage. As the authors of a KU LEUVEN study note, because sertraline is a clinically used drug that can safely be used in humans, it might make a good candidate.

Prof. De Keersmaecker explained that when used with other therapeutics, the drug strongly inhibited the growth of cancer cells in the mice.

The authors of the study concluded: Collectively, this work provides a novel and cost efficient treatment option for the rapidly growing list of serine/glycine synthesis-addicted cancers.

Christy Maksoudian from the NanoHealth & Optical Imaging Group team at KE LEUVEN is excited about the promise of nanotechnology for the treatment of cancer. She told MNT that because of the unique properties that emerge at such a small scale, nanoparticles can be designed in a multitude of ways to exhibit specific behaviors in organisms.

Currently, she explained, many available nanoformulations in the clinic are composed of organic materials because of their biocompatibility and safety. In this context, organic refers to compounds that include carbon.

However, she explains that inorganic nanomaterials, which do not contain carbon, also hold promise for cancer treatment because they possess further functionalities.

For instance, some magnetic nanoparticles, such as those of superparamagnetic iron oxide, can be magnetically guided toward the tumor, while gold nanoparticles generate heat upon exposure to near-infrared light and can, therefore, be used for photothermal therapy (via tumor tissue ablation).

In short, it is possible to introduce gold nanoparticles to the bloodstream of people with cancer. From there, these nanoparticles accumulate in tumors because tumors have particularly leaky blood vessels. Once that region is exposed to near-infrared light, the gold nanoparticles heat up and, consequently, kill cancer cells.

Because of the potential of such broad range of nanomaterial designs, there are always novel cancer therapies being developed.

Christy Maksoudian

I am excited to take part in this movement with my work on copper oxide nanoparticles. Maksoudian and her colleagues use copper oxide nanoparticles doped with 6% iron.

Maksoudian told MNT that these nanoparticles exploit intrinsic metabolic differences between cancer cells and healthy cells to induce high levels of toxicity in cancer cells while only causing reversible damage in healthy tissue.

The fact that such cancer-selective properties can arise due to minor modifications of the nanoparticles at the nanoscale is truly extraordinary and reaffirms the significant role that nanomedicine can play in expanding the treatment landscape for oncology.

Cancer is complex, so approaches to its treatment must match that complexity. As the summaries above demonstrate, scientists are not short on ingenuity, and the battle against cancer continues at pace.

Read the first part of our series on cancer researchers and their exciting work here.

Read more from the original source:
Cancer research: New advances and innovations - Medical News Today

Recommendation and review posted by Bethany Smith

This article was originally published here

Breast Cancer Res Treat. 2021 Jun 4. doi: 10.1007/s10549-021-06258-9. Online ahead of print.

ABSTRACT

BACKGROUND: Hereditary breast and ovarian cancer syndrome (HBOC) and Lynch syndrome (LS), the most common inherited cancer syndromes, are attributed to a single heterozygous pathogenic variant (PV) in BRCA1/2 or in a DNA MMR gene, respectively. Little is known about the phenotype in double heterozygotes who carry PVs in both genes.

METHODS: Carriers of double-PVs in any DNA MMR gene and BRCA1/2 attending one of three tertiary oncogenetic clinics between 1/2005 and 1/2020 were identified by database search, and their relevant data were retrieved and analyzed.

RESULTS: Eleven double carriers from four seemingly unrelated Ashkenazi Jewish families were evaluated. All carried an Ashkenazi Jewish founder BRCA PV, BRCA2 c.5946delT/c.6174delT (n = 10) or BRCA1 c.185delAG (n = 1). Four carried the MSH2 c.1906G > C founder PV, and 3, the MSH6 c.3984_3987dupGTCA founder PV; 3 patients had the MSH6 c.3956_3957dup PV. Eight double carriers (73%) had cancer: breast cancer (5 cases, 2 bilateral), melanoma (2 cases), urothelial cancer (2 cases), and colon, endometrial, prostate, cutaneous squamous cell cancer, glioblastoma, gastric stromal tumor, and lymphoma (1 case each). Six carriers had 1-2 tumors, one had 3 tumors, and one had 5 primary tumors. Age at diagnosis of the first tumor was 36-76 years. All carriers met NCCN BRCA1/2 testing criteria, and 3 met the revised Bethesda guidelines.

CONCLUSIONS: This case series, supported by the literature, suggests that the phenotype of double MSH2/6 and BRCA1/2 carriers is not associated with early disease onset or a more severe phenotype. The findings have implications for improved genetic testing guidelines and treatment strategies.

PMID:34086170 | DOI:10.1007/s10549-021-06258-9

Original post:
Double heterozygotes of BRCA1/BRCA2 and mismatch repair gene pathogenic variants: case series and clinical implications - DocWire News

Recommendation and review posted by Bethany Smith

(India, Maharashtra, Pune)Report Covers the Detailed Pre and Post COVID-19 Impact Analysis on Direct-To-Consumer (DTC) Genetic Testing Market

This report conducts the global Direct-To-Consumer (DTC) Genetic Testing market size based on capacity, value, production and consumption data across the region such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. This study categorizes the global Direct-To-Consumer (DTC) Genetic Testing breakdown data by manufacturers, region, type and application, also analyzes the market status, market share, market drivers, upcoming opportunities, CAGR, trends, and challenges, risks and entry barriers, sales channels, distributors, SWOT, PESTLE, and Porters Five Forces Analysis.

The Direct-To-Consumer (DTC) Genetic Testing Market is expected to grow from USD XX billion in 2020 to USD XX billion by 2027, at a Compound Annual Growth Rate (CAGR) of XX% during the forecast period. The research provides insights for the global Direct-To-Consumer (DTC) Genetic Testing market based on different types, end-users and regions, and competitive landscape of these segments is analysed in more detail.

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Various market influence factors are taken into consideration in the analysis, and potential developing factors for different types, end-users, regions, and countries are also included in the report in order to figure out the most promising development trends in the Direct-To-Consumer (DTC) Genetic Testing industry. The market capacity and consumption potential of more than 35 major players are covered in the research, providing valuable opinions of strategic adjustments for existing groups and new entrants, across the regions such as North America, Europe, Asia Pacific and Latin America, Middle East & Africa.

The Snapshot of Global Direct-To-Consumer (DTC) Genetic Testing Market Segmentations:

The Key Direct-To-Consumer (DTC) Genetic Testing Market Players Associated with the Industry are:, Color Genomics, Inc., Gene by Gene, Ltd., Laboratory Corporation of America Holdings, 23andMe, Inc., Sonora Quest Laboratories LLC, Request A Test, Ltd., Direct Laboratory Services, LLC, Mapmygenome India Limited, Any Lab Test Now, Ancestry.com, LLC, Xcode Life Sciences, Quest Diagnostics, Inc., Counsyl, Inc., Positive Bioscience, Inc.

Market, By Types:, Carrier Testing, Predictive Testing, Ancestry & Relationship Testing, Nutrigenomics Testing

Market, By Application:, Hospital, Doctors Office, Other

By Region, North America, U.S., Europe, UK, France, Germany, Asia Pacific, China, Japan, India, Latin America, Brazil, Middle East and Africa

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There are 4 scenarios of recovery, 1) V shaped recovery rapid decline sharp bottom-rapid recovery, 2) U shaped recovery -rapid decline early- gradual at bottom slow recovery at first faster recovery later on, 3) L shaped recovery rapid decline then slow growth, 4) W shaped recovery -rapid decline rapid recovery- return of virus another sharp decline -recovery

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Some Point of Table of Content:

Chapter One: Direct-To-Consumer (DTC) Genetic Testing Introduction and Market Overview

Chapter Two: Executive Summary

Chapter Three: Industry Chain Analysis

Chapter Four: Global Direct-To-Consumer (DTC) Genetic Testing Market, by Type

Chapter Five: Direct-To-Consumer (DTC) Genetic Testing Market, by Application

Chapter Six: Global Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Regions

Chapter Seven: North America Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Eight: Europe Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Nine: Asia Pacific Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Ten: Middle East and Africa Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Eleven: South America Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Twelve: Competitive Landscape

Chapter Thirteen: Industry Outlook

Chapter Fourteen: Global Direct-To-Consumer (DTC) Genetic Testing Market Forecast

Chapter Fifteen: New Project Feasibility Analysis

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About us.The Market Insights is a sister company to SI Market research and The Market Insights is into reselling. The Market Insights is a company that is creating cutting edge, futuristic and informative reports in many different areas. Some of the most common areas where we generate reports are industry reports, country reports, company reports and everything in between. At The Market Insights, we give our clients the best reports that can be made in the market. Our reports are not only about market statistics, but they also contain a lot of information about new and niche company profiles. The companies that feature in our reports are pre-eminent. The database of the reports on market research is constantly updated by us. This database contains a broad variety of reports from the cardinal industries. Our clients have direct access online to our databases. This is done to ensure that the client is always provided with what they need. Based on these needs, we at The Market Insights also include insights from experts about the global industries, market trends as well as the products in the market. These resources that we prepare are also available on our database for our esteemed clients to use. It is our duty at The Market Insights to ensure that our clients find success in their endeavors and we do everything that we can to help make that possible.

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Direct-To-Consumer (DTC) Genetic Testing Comprehensive Analysis on Global Market Report by Company, by Dynamics, by Region, by Type, by Application...

Recommendation and review posted by Bethany Smith

This Cryonics Technology market report provides the best business insight and understanding to help key players stay ahead of the competition. It also detects emerging trends and forecasts future market numbers, trends, and characteristics. This Cryonics Technology market report offers the most effective action strategies for dealing with the current market situation and establishing a marketplace. It also helps to improve and enhance the companys position. This Cryonics Technology market report allows industries to easily assess and compare their results to that of others. This Cryonics Technology market report provides a straightforward view of market tactics, which can assist companies in achieving massive profits. It also offers a good picture of trade restraints, product releases, business penetration in new areas, and technical developments and advancements.

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Segmentation on the Basis of Application:Animal husbandry Fishery science Medical science Preservation of microbiology culture Conserving plant biodiversity

Global Cryonics Technology market: Type segmentsSlow freezing Vitrification Ultra-rapid

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Cryonics Technology Market2 Market Trends and Competitive Landscape3 Segmentation of Cryonics Technology Market by Types4 Segmentation of Cryonics Technology Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Cryonics Technology Market in Major Countries7 North America Cryonics Technology Landscape Analysis8 Europe Cryonics Technology Landscape Analysis9 Asia Pacific Cryonics Technology Landscape Analysis10 Latin America, Middle East & Africa Cryonics Technology Landscape Analysis 11 Major Players Profile

Furthermore, this study sheds light on a few key points that will drive the global markets financial flow. It also focuses on a number of key sources that can be used in the market to achieve the best results and gains. It also covers some critical approaches for exploring global market opportunities and expanding the company. In this Cryonics Technology market report, a thorough regional study is carried out, with a focus on a few main regions such as Europe, China, North America, Japan, India, and South America. Key players can easily gain a prominent position in the market with the aid of this detailed market research. It also depicts the COVID-19 global effects on various segments and countries.

In-depth Cryonics Technology Market Report: Intended AudienceCryonics Technology manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Cryonics TechnologyCryonics Technology industry associations and research organizationsProduct managers, Cryonics Technology industry administrator, C-level executives of the industriesMarket Research and consulting firms

It reveals macroeconomic factors as well as parent industry patterns. It also shows market rivalry among the most important companies and market experts. This Cryonics Technology Market report includes significant market aspects such as channel features, end-user market data, and key players. From the year 2021 to 2027, market data is provided at the regional level to show growth, sales, and revenue by region. Through this Cryonics Technology market report, it is possible to research potential shortages as well as problems faced by a number of critical industries.

About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Cryonics Technology Market Pegged for Robust Expansion by 2027 Covid-19 Analysis The Courier - The Courier

Recommendation and review posted by Bethany Smith

Cell and gene therapies (CGTs) are poised to revolutionize the landscape of biologic drugs that treat diseases and offer hope in areas where there was previously none. There are 20 FDA-approved CGTs, and this number is expected to grow significantly. Regulators predict that by 2025, they will approve 10 to 20 CGT products a year, based on an assessment of the current pipeline and the clinical success rates of these products. Pharma and biotech companies clearly recognize the potential of CGTs, with 16 out of 20 of the world's largest (by revenue) biopharma companies adding CGT assets to their product portfolios. Valuable insights into what drives progress, to new innovations on the horizon, and the critical challenges that sponsor companies face in developing these treatments were provided by Thomas VanCott, Ph.D., Vice President and Global Head of Product Development, Catalent Cell and Gene therapy. VanCott has over 15 years of experience bringing vaccines and many different therapies from clinical stages to the commercial marketplace, therefore providing a deep understanding of how to successfully navigate the CGT arena.

VanCott: Advancements in technology is a huge accelerator. Currently, the availability of manufacturing platforms and pathways can move these CGTs from the lab to the clinic in a reasonable time frame. Meanwhile, adeno-associated virus has proved to be a safe and flexible gene-delivery mechanism, and with the emergence of other suitable viral vectors and non-viral delivery methods, there are many viable options out there.

Another significant driver has been the early successes with products such as Kite's Yescarta and Novartis'Kymriah. Cell therapy is generating a lot of excitement, and it is not just limited to CART T-cells, but to widely divergent cell types, such as natural killer cells, macrophages and stem cells that are broadening CGT applications.

We have flexibility of viral and non-viral vectors for gene therapies, and different cell types to adapt for cell therapies. We have manufacturing processes in place that can get us into the clinic. Success generates excitement across the board, from scientists, patients and advocacy groups to investors. We have a lot of companies in the space, a lot of investment and a deep pipeline, which is making the future look very promising.

VanCott: Developing scalable manufacturing processes for CGTs within a reasonable cost is a critical challenge. The public is probably willing to pay more for some of these early therapies, but if these really become a staple in doctors'medical arsenals, we will need to work to get these prices down, and the best way to do that is to have more efficient and more scalable processes.

CGTs are so varied and complex that fully characterizing each product's activity is no trivial matter. Consequently, the development of better analytics will be a formidable challenge for this industry.

A lack of effective preclinical models to predict the safety of CGTs is another challenging area for sponsor companies. Safety issues with CGTs get a lot of attention; we need to strive to develop better models that can predict problems before moving these treatments to patients and commencing clinical trials.

The COVID-19 pandemic exacerbated a major problem for the CGT industry, that of supply chain shortages. We have only limited resources and raw materials, and so keeping your supply chain intact to continue manufacturing has definitely been one of the biggest challenges recently.

VanCott: I predict that future innovative therapies will be created using induced pluripotent stem cells. Even though these cells are really difficult to work with, they have almost unlimited applications because they can differentiate into any cell type.

Continued innovation in non-viral gene-delivery methods that will facilitate methods such as tissue-targeting and repeat dosing will propel CGT products forward. There's always been a lot of work in non-viral delivery, but we're seeing an acceleration of that because of the success of the Moderna and Pfizer COVID-19 vaccines that use lipid nanoparticles (LNPs) for effective delivery of mRNA. In fact, without these LNPs, there would be no mRNA vaccines for COVID-19.

Innovations in the field will lead to treatment of other diseases, such as diabetes, Parkinson's and macular degeneration, that affect much larger populations. Historically, CGT has been mostly reserved for treating rare diseases, but I am confident this will change in the near future. Higher-yield CGTs are needed for this to become a reality, and I foresee a surge in allogeneic cell therapies, which could mean having off-the-shelf types of products on the market. In addition, coupling cell therapies with some of these new gene-editing technologies, such as CRISPR/Cas9, you can start to further engineer cells to address countless therapeutic needs.

Data from clinical efficacy and safety of CGTs will unquestionably shape the field. There is great promise that ten years from now, we're going to have many new gene therapy treatments for monogenic diseases and certainly more cell therapies. CGTs are here to stay, and they're going to become an important part of a doctor's arsenal for treating patients.

VanCott: My advice to sponsor companies is to develop more robust processes early on to analyze the critical quality attributes of their products, to formulate their target product profile and to get their manufacturing process commercial-ready all within an earlier time frame. Typically, the development pathway for CGTs is much faster than with more conventional therapies. Instead of taking ten years to develop a product, you're cutting that time in half. Sponsor companies too often underestimate the importance and the time it takes to get the analytics optimized. Spending a significant time at the beginning of the development process to optimize each step and avoid moving forward in a rush with a process that is not rigorous and reproducible is very important.

Seek out CDMO partners that can handle accelerated timelines and give preference to those CDMOs with a fully integrated service offering. In the past, it was pretty standard for sponsor companies to work with a CDMO for the early-stage development, including tech transfer and process development, and maybe clinical Phase 1 and 2, then switch to another CDMO that had the larger-scale capacity and could handle Phase 3 and commercial stages of development. In today's CGT field, you do not have those long timelines, and clients do not have the luxury of switching CDMOs. Successful CDMOs need to offer everything from that initial tech transfer all the way up through commercial production.

Detailed and long-term planning is needed for establishing a reliable supply chain for CGT development. With the COVID-19 pandemic creating a strain on resources, it has not been easy recently to maintain a steady supply chain. However, there is some good news, in that the market will respond to increasing demands. As more companies start producing larger amounts of the needed supplies, and once we get through this initial high demand, there will be more supply making the scarcity of resources a temporary issue. As CGTs become approved for larger indications in the future, the ability of the supply chain to be ramped up, as it was for COVID-19 vaccines, will be a valuable element in the future success of these therapies for the wider population.

To hear from more of the industry's leading CGT specialists, register for the BioPharma Dive webinar, Gene Therapy at a Crossroads: The Challenges and Opportunities Ahead

See the original post here:
Innovation in cell and gene therapy: Insights from an industry specialist - BioPharma Dive

Recommendation and review posted by Bethany Smith

A five-month-oldbaby has become the first patient in England treated with a potentially life-saving drug on the NHS that can prolong the lives of children with spinal muscular atrophy.

rthur Morgan, who was diagnosed with the condition earlier this month, received the one-off gene therapy at Evelina London Childrens Hospital on May 25.

Until two years ago, there were no treatment options available for children with spinal muscular atrophy (SMA), which is the leading genetic cause of death for children.

But babies could potentially have the ability to sit, crawl and walk after being treated with US gene therapy Zolgensma, which has been labelled the most expensive drug in the world.

Zolgensma, which has a list price of 1.79m (2.08m)per dose, was made available on the NHS after the health service struck a deal with manufacturers Novartis Gene Therapies in March.

Baby Arthur, who was born six weeks premature in December, underwent the gene therapy infusion last week after being diagnosed with SMA less than three weeks earlier.

His father Reece Morgan (31) who works as a self-employed plasterer, said: When we found out that Arthur would get the treatment, and be the first patient, I just broke down.

It had been such a whirlwind few weeks, filled with lots of anxiety and adjustment as we learned about his condition and what it might mean for him and our family.

We still dont know what the future will hold, but this gives Arthur the best possible chance to give him the best possible future.

Babies born with Type 1 SMA, which is the most common form of the condition, experience progressive muscle weakness, loss of movement, difficulty breathing, and have a life expectancy of just two years.

Four NHS centres have now been commissioned across the country to administer the treatment, including Evelina London Childrens Hospital, where Arthur was treated.

NHS chief executive Sir Simon Stevens said: It is fantastic news that this revolutionary treatment is now available for babies and children like Arthur on the NHS.

The NHS Long Term Plan committed to securing cutting edge treatments for patients at a price that is fair to taxpayers.

Original post:
The 2m-a-dose therapy is just what doctor ordered for baby Arthur - Independent.ie

Recommendation and review posted by Bethany Smith

NEW YORK Myriad Genetics unveiled data at the American Society of Clinical Oncology's virtual annual meeting demonstrating that its polygenic score for assessing breast cancer risk can provide accurate estimates for women regardless of their ancestry.

The company launched riskScore three years ago initially as a test for estimating the five-year and lifetime risk of breast cancer for women who had never had the disease and who do not have a mutation in breast cancer-associated genes detected by its next-generation sequencing myRisk Hereditary Cancer test. However, the availability of the around 86-SNP polygenic risk score to date has been restricted to women who self-identified as having European and Ashkenazi Jewish ancestry.

Now, having recalibrated riskScore to provide more accurate breast cancer risk estimates for women in the US, regardless of their genetic ancestry, Myriad is planning to launch this version of the test later this year for women who qualify for myRisk, which gauges mutations in multiple genes conferring high or moderate risk for breast cancer. In 2022, the company will offer riskScore as a standalone, direct-to-consumer (DTC) test for women who aren't eligible for the myRisk test based on their personal and family history of breast cancer.

Polygenic risk scores rely on the combinatorial power of many SNPs associated with disease risk, but these SNPs have largely been identified in genome-wide association studies done in patients of European ancestry. As such, these scores tend to overestimate disease risk and are less accurate in discerning between high- and low-risk groups in those of non-European ancestry.

For example, studies have shown that Black women have similar incidence of breast cancer compared to white women in the US. But Myriad's 86-SNP riskScore developed for women of European ancestry overestimates the breast cancer risk in Black women by nearly twofold, said Holly Pederson, who was involved in the effort to recalibrate riskScore and directs medical breast services at the Cleveland Clinic.

Myriad wanted to address this limitation within its test and has been refining riskScore in Hispanic, African American, and other racial groups for several years. Pederson presented the culmination of those efforts at ASCO's annual meeting and unveiled a new 93-SNP riskScore, re-engineered for all ancestries using data from more than 275,000 women.

The new iteration of riskScore will not only test women for 93 breast cancer-associated SNPs, but also for 56 ancestry-associated genes, in order to calculate an ancestry-specific result that corresponds to their chances of developing breast cancer in the next five years and over their lifetime. This will preclude women from having to self-report their ancestry, which can be inaccurate, especially for non-European women. "What I found during my years of seeing patients is that many patients weren't entirely sure of their ancestry, and this will no longer be a barrier for care," said Nicole Lambert, president of Myriad Genetic Laboratories.

Weighted by genetic ancestry

The 93-SNP riskScore is weighted according to 56 SNPs associated with ancestral lineage from Africa, East Asia, and Europe, the three places that account for most of the genetic diversity in the US. "There are multiple sub-clusters within each of those [continental] clusters, so using three ancestries is a simplification of the full diversity of human populations," Pederson acknowledged during her presentation at the meeting. "However, these three ancestries together should reasonably represent most of US human genetic diversity."

Data from more than 189,000 women were used to develop the score, and it was validated in data from more than 89,000 women. In these cohorts, 23 percent of women had breast cancer and around 30 percent had a first-degree relative with the disease. Roughly 10 percent of women in these cohorts self-reported as Black or African, around the same proportion self-reported as Hispanic, and around 2 percent self-reported as Asian.

To develop the score, researchers led by Myriad CSO Jerry Lanchbury and Elisha Hughes, the company's director of research biostatistics, first developed polygenic risk scores specific to people of African, Asian, and European descent using data from its own hereditary cancer testing customers with self-reported race, as well as from large consortia and genome-wide association studies. For each of the patients in the development cohort, researchers determined their "fractional ancestry" from the three continents using the 56 SNPs, which then allowed for the ancestry-adjusted calculation of their risk for developing breast cancer based on the 93 SNPs.

"The different alleles found for each SNP in an individual woman are interpreted not only as a function of her ancestral composition, but also on the frequency of that allele's presence in one of the three continental ancestries because they are each different," Pederson said. "An individual woman's polygenic risk score therefore depends not only on her genotype, but also on her ancestral derivation and the frequency of an allele in a given ancestry."

In the validation cohort, researchers wanted to see how well the re-engineered riskScore distinguished between women at high and low-risk of developing breast cancer across ancestries and how the new score compared to the 86-SNP test for women of European descent. The study showed that the 93-SNP test was generally an improvement over the 86-SNP test in terms of breast cancer risk predictions for women of all ancestries. In their abstract, the authors noted that the Asian cohort was too small to demonstrate that either score was superior.

Furthermore, the validation study showed that the women with the recalibrated riskScore placed in the highest risk category the top 1 percent in fact had a two to threefold greater chance of developing breast cancer compared to average-risk women. For women of all self-reported ancestries, except Black women, if the test placed them in the top decile in terms of risk, they were twice as likely to develop breast cancer compared to average-risk women.

Self-reported African or Black women who were deemed by riskScore to be in the top decile in terms of risk had a 44 percent greater chance of developing breast cancer risk. Pederson said during her presentation that the re-engineered riskScore's ability to assess self-reported Black women's breast cancer risk was "significantly improved" compared to the earlier test but still "sub-optimal." She added that the new score's risk discrimination in Black women will likely become more precise with additional data.

"We have known for some time that genomically-based breast cancer risk stratification was biased towards SNPs from women with European ancestry and did not perform as well in women ofother ancestries," said Corey Speers, assistant professor of radiation oncology at the University of Michigan Rogel Cancer Center. "This study represents an important step to 'level the field' for women of disparate ancestries and more accurately estimate breast cancer risk in these women," Speers, who researches the biology of aggressive breast cancers and wasn't involved in the riskScore study, added.

More definitive guidance

Cleveland Clinic, where Pederson works, hasn't yet incorporated polygenic risk scores into standard disease risk estimation workflows. The academic medical center is participating in a prospective study, called GENRE-2, using a 300-SNP breast cancer polygenic risk score developed by Fergus Couch at the Mayo Clinic. In that study, researchers are tracking if this score helps patients make decisions about breast cancer prevention, such as whether to take endocrine therapy. https://clinicaltrials.gov/ct2/show/NCT04474834?term=GENRE-2&draw=2&rank

Outside of the research setting, however, the lack of validation in non-European populations has been a big reason holding up adoption of polygenic risk scores for breast cancer and other diseases. "Clinically, the polygenic risk score is really in its infancy," Pederson said. "Previous to this, really due to concerns over applicability in non-European populations and interpretation and communication of the results, we have not utilized polygenic risk scores at Cleveland Clinic."

Even though Myriad has been offering the 86-SNP riskScore for European women as part of myRisk at no additional cost, Cleveland Clinic has been opting out of that information, according to Pederson. This study, she believes, may very well change that, since to the best of her knowledge Myriad's test is the only breast cancer polygenic risk score that has been calibrated to be informative for all ancestries.

Speers noted as a positive that the training and validation cohorts in the study presented at ASCO included tens of thousands of women and were well balanced in terms of the factors that are most likely to influence breast cancer risk. He is eagerly awaiting peer-reviewed publication of the data, upon which he expects that riskScore will represent "an important step forward for providing equitable and accurate test results for women of all ancestral backgrounds."

With the increasing use of multi-gene tests, like myRisk, which look for pathogenic variants in moderate-risk genes alongside well-known high-risk genes like BRCA1/2, more patients are receiving results where the management implications aren't well established. This can be particularly difficult when women's personal or family history of cancer doesn't offer straightforward clues as to their future cancer risks.

Myriad and others developing polygenic risk scores are betting that these tests will providerisk information when large NGS panels turn up negative or even refine risk estimates when considered alongside mutations in moderate-penetrance genes, and relieve uncertainties around patient management. "If patients have a genetic mutation in CHEK2, which is a moderate-risk gene, we tell them they have an estimated lifetime [breast cancer] risk of about 30 percent," Pederson said. "But when you look at the risk stratification that can be achieved by a polygenic risk score, patients may have a risk as low as 6.6 percent over the course of her life or a 70 percent risk, which is similar to a patient with a BRCA1/2 [high-risk] mutation."

Women she treats overwhelmingly want to know this information, Pederson said.

Although she believes that Myriad's new riskScore is "sufficiently validated and calibrated" in all ancestries, she would like to see the test factor in patients' clinical features that also increase their chances of developing breast cancer. At her own practice, patients' decisions about having preventive mastectomies or oophorectomies to mitigate their cancer risk isn't just based on genetic testing but also on a variety of other clinical factors, as well as patients' own priorities for their health and family planning.

The genetic test result is "just one piece of information," she said. "While it is useful in and of itself, it'll be even more useful for a woman to get an estimate in combination with those other [clinical] factors. It just allows for more precise estimates and better conversations."

Myriad's 86-SNP score for European women incorporates the Tyrer-Cuzick risk model, which evaluates breast cancer risk based on features like age, body mass index, age of first period, and family history of cancer. Myriad is working on integrating clinical risk features into the recalibrated riskScore, Pederson said, adding that this work will likely be presented at a medical meeting by year end.

Access to all

Myriad is planning to launch the recalibrated riskScore for all ancestries later this year, but in the near-term will maintain it as a physician-ordered test offered alongside myRisk. Next year, however, the company wants to launch riskScore as a standalone test through a DTC model for the estimated 93 million women who don't qualify for testing for high- or moderate-penetrance breast cancer risk genes based on stringent personal and family cancer history criteria, as well as the National Comprehensive Cancer Network's guidelines. "This will allow us to provide a precise risk estimate to all women: myRisk for those who qualify, standalone riskScore for those who dont," said Lambert.

Myriad's DTC plans for riskScore also raises questions about how the company will navigate the regulatory landscape. The US Food and Drug Administration has been clear about its intent to regulate labs marketing genetic tests for assessing disease risk directly to consumers.

23andMe is the only company that currently sells FDA-authorized genetic tests for gauging disease risk, including for cancer, which people can order online without any physician involvement. Other companies offering testing in CLIA-certified labs have found ways around FDA oversight by using third-party physician networks to review and approve customer's online orders. However, this is a controversial model because often the physicians approving test orders don't have much interaction with the patients.

Myriad demurred on its specific regulatory plans, saying that it is still ironing out the specific DTC model it will employ when it launches riskScore as a standalone test next year. "We are currently assessing the regulatory requirements, talking with stakeholders, and creating the specific launch plans," Lambert said.

Pederson backed efforts to broaden access to cancer risk testing, recognizing that using current testing guidelines, largely based on personal and family history of cancer, the healthcare system has identified only a minority of patients with mutations in high-risk genes. At the same time, the rapid introduction of broad NGS panels has made it difficult for physicians lacking genetic expertise to accurately interpret test reports.

As such, a broad marketing strategy for polygenic risk scores must include a robust education plan for patients and providers, Pederson said, including genetic counseling support and resources to help primary care providers interpret test reports and relay nuanced risk information to patients.

Lambert assured that Myriad currently makes genetic counselors available to any doctor or patient ordering germline genetic testing and that these resources would also be available in the consumer-facing service. "We are in the process of evaluating what other services would be desirable as we prepare for the launch of the consumer version in 2022," she said.

Ultimately, given the popularity of DTC genetic testing, "something real like this, if it is priced right and marketed correctly, would really provide women with information that they really want," Pederson said.

See original here:
Myriad Genetics Recalibrates Breast Cancer PRS for All Ancestries in Anticipation of Broader Launch - Precision Oncology News

Recommendation and review posted by Bethany Smith

Breast cancer is caused by mutations, or damage, to the DNA in breast cells. Exactly what triggers this change is unknown, but many people will spend countless hours trying to figure it out.

What is known is that there are risk factors that may increase your chances of getting breast cancer. Some of them, like age, family history, and dense breasts, cant be changed. Others are determined by lifestyle factors that can often be controlled.

In the United States, its estimated that around 30% of new cancer diagnoses in women will be breast cancer. This makes early detection and possible prevention very important. In this article, well go over the potential causes of breast cancer and what you can do about them.

Breast cancer originates in breast tissue. Its caused by changes, or mutations, in breast cell DNA. These mutations cause cells to grow abnormally and divide quicker than healthy cells do. The abnormal cells accumulate, forming a malignant breast mass, also known as a lump.

Your immune system may be able to successfully fight some abnormal cells. but the ones that continue to grow may spread, or metastasize, throughout the breast to the lymph nodes or other parts of the body.

When breast cancer spreads, the malignant tumors it causes in other places are still referred to as breast cancer.

What exactly triggers DNA changes in breast cells isnt clear. Two people can have the same or similar risk factors, but only one might develop breast cancer.

Age is the most significant risk factor for breast cancer. Most breast cancer cases are diagnosed in people over 55 years old.

But your genetics and external factors, like smoking, also have an impact. Genetic risk factors cant be changed, but lifestyle choices that put you at higher risk can be altered.

Its also likely that for many people, multiple risk factors both genetic and environmental have an impact when several are present.

People born with a vagina are at a significantly higher risk for getting breast cancer than those born without one. According to the Centers for Disease Control and Prevention (CDC), only about 1 in every 100 cases of breast cancer diagnosed in the United States is in a man.

You can inherit a gene mutation that puts you at higher risk for breast cancer from either biological parent. About 5 to 10 percent of all breast cancer cases are caused by hereditary gene mutations. The most common type is a mutation in the BRCA1 or BRCA2 gene.

If you have a BRCA1 or BRCA2 gene mutation, your risk for ovarian cancer is also increased.

There are other inherited gene mutations that can increase your risk as well, including:

If you have several close relatives with breast cancer, you may be more likely to develop it. This is especially true if you have one or more first-degree relatives with breast cancer. A first-degree relative is anyone you share at least 50 percent of your genetics with, like a parent or child.

Having a family history of breast cancer may mean you share the same genetic mutation. But there are other potential explanations here that have nothing to do with genetics.

For example, it may mean you share lifestyle choices that put you at greater risk. It may also be caused by environmental factors, like living in an area where chemical exposure, air pollution, or water pollution levels are high.

You may be more likely to develop ER-positive breast cancer if you began menstruating at a younger age or started menopause later than usual. This is because theres a longer period of time when breast cells are affected by estrogen and possibly, progesterone.

Never having given birth also increases your lifetime exposure to estrogen.

If you have given birth, every 12 months that you nurse your child reduces your chance of getting breast cancer by about 4.3 percent.

Smoking cigarettes and using nicotine products modestly increases the risk for breast cancer. The younger you were when you started smoking, the greater your risk. Smoking also increases your risk to a greater degree if you have a family history of the disease.

The International Agency for Research on Cancer has determined that alcohol is a carcinogen thats causally related to breast cancer risk.

The greater your alcohol intake, the higher your risk may be. But even one drink per day increases risk in both premenopausal and postmenopausal women.

Toxins and chemicals can be found in:

Some toxins are known as endocrine disruptors, or endocrine disrupting compounds. These toxins can mimic the effects of estrogen in the body and may increase breast cancer risk. Endocrine disruptors include:

Certain foods may increase your risk of breast cancer. Foods to limit or avoid include:

Because fat cells produce estrogen, being overweight or obese can be a significant risk factor as is having a sedentary lifestyle, which may contribute to increased weight.

Women whove previously had breast cancer or are postmenopausal have an even higher risk if theyre overweight or are living with obesity.

Hormonal birth control, including the pill, ring, and IUD, may increase your breast cancer risk slightly. This may be greater if you use hormonal birth control for 5 years or more. If you have a family history of breast cancer, your risk may be higher.

Hormone replacement therapy (HRT) poses a much greater risk. HRT isnt recommended for symptom relief of menopause in people who have other risk factors for breast cancer.

Early detection wont stop you from getting breast cancer, but it can help to ensure a better outcome. Talk with a doctor about how often you should get a mammogram. If you have dense breasts, getting regular ultrasounds may also be beneficial.

Adjustments to your lifestyle may also help. These include:

The following tips may aid with recovery and with avoiding breast cancer recurrence:

Breast cancer is caused by mutations in breast tissue cells. The underlying risk factors for breast cancer include genetics, environmental toxins, and lifestyle factors, but a definite cause hasnt been identified.

Make proactive choices to reduce your risk of breast cancer. These include cutting down on smoking and alcohol use, as well as maintaining a healthy weight.

Go here to read the rest:
Breast Cancer Causes: Genetics, Prevention, and More - Healthline

Recommendation and review posted by Bethany Smith

EAST HANOVER, N.J., June 3, 2021 /PRNewswire/ -- Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival (PFS) (HR: 0.18*, p < 0.0001)3. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)]1.While this analysis did not reach statistical significance (Hazard ratio for OS (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30, two-sided))1, the analyses of overall survival may have been impacted by multiple factors, including the crossover of patients from the control arm receiving subsequent radioligand therapy (36% of patients) as well as heterogenous subsequent anti-cancer treatments in both study arms1.No new safety signals emerged in the final analysis1. These results will be presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.

Jonathan Strosberg, MD, Principal Investigator and Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, said, "Lutathera plus long-acting octreotide was associated with a nearly 12-month difference in median overall survival compared to high-dose long-acting octreotide in these difficult to treat patients with inoperable midgut NETs progressing under standard dose octreotide LAR treatment.While not statistically significant, I consider this difference to be clinically relevant for these patients. It is also important to emphasize that PFS was the primary endpoint of this study.Moreover, 36% of patients in the control arm crossed over to receive subsequent radioligand treatment, which may have impacted the comparison of survival between both study arms."

"We are proud of our 30-year legacy as an innovator for patients in the neuroendocrine tumor community," said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. "Since its approval by the European Commission in 2017 and the FDA in 2018, Lutathera has been administered to more than 9,000 gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients in Europe and the United States1. We believe in the potential of targeted radioligand therapy and are investing in new discovery and expansion of this important platform, including exploration of new radioisotopes and combinations with complementary mechanisms of action, such as immunotherapy and inhibitors of DNA damage response."

At this final analysis, no new safety signals emerged in the long-term safety follow-up with a median of 6.3 years. In terms of secondary hematological malignancies, no new cases of MDS or acute leukemia were reported in the long term follow up4.

Radioligand therapy combines a targeting compound that binds to receptors expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication and may lead to cell death5-7. In the case of Lutathera, it binds to somatostatin receptor type 2, which is over-expressed on certain types of cells, such as gastroenteropancreatic neuroendocrine tumor cells8,9.

Novartis has established global expertise and specialized supply chain and manufacturing capabilities across its network of four radioligand therapy production sites, and is further increasing capacity to ensure delivery of future targeted radioligand therapies to patients in need. Novartis is the only pharmaceutical company which is pursuing four different cancer treatment platforms. These include targeted radioligand therapy, cell and gene therapy, targeted therapy and immunotherapy, with an opportunity to combine these platforms for the best outcomes for each cancer patient.

Visithttps://www.hcp.novartis.com/virtual-congress/a-2021/for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO21 Virtual Scientific Program data presentations (for registered participants).

* HR: 0.21 (0.13, 0.32) in the US Package Insert

About NETTER-1NETTER-1 is a Phase III international, multicenter, controlled, randomized study that compared treatment using Lutathera every eight weeks plus best standard of care (octreotide LAR 30 mg) to 60 mg of octreotide LAR (dosed every four weeks) in patients with inoperable midgut NETs progressing under standard dose octreotide LAR treatment and overexpressing somatostatin receptors3.

The primary endpoint was to compare the progression-free survival (PFS) after treatment with Lutathera plus octreotide LAR 30 mg versus octreotide LAR 60 mg using RECIST 1.1 criteria3. Secondary trial endpoints included comparing objective response rate, overall survival, time to tumor progression, duration of response and safety between the two study arms3.

About GEP-NETs Neuroendocrine tumors (NETs) are a type of cancer that originate in neuroendocrine cells throughout the body. NETs are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis10-11. In many cases, NET diagnosis is delayed until patients have advanced disease12. Symptoms such as fatigue, diarrhea, and abdominal pain can occur on a daily basis13. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are subdivided into two categories: tumors of the gastrointestinal (GI) tract and pancreas14. There is a need for additional treatment options for inoperable or advanced GEP-NET, including those who have progressed while taking first-line somatostatin analogs.

The estimated age-adjusted incidence, or rate of new cases of NETs in the United States is approximately 6.98/100,000 per year (as of 2012), while the estimated 20-year limited-duration prevalence for 2014, based on the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database, was 171,32111. Even though NETs have historically been considered to be rare (orphan disease), their incidence has grown over 500% over the last 3 decades 10,11,12,15.

About LutatheraLutathera (lutetium Lu 177 dotatate) is an Advanced Accelerator Applications product approved in the United States for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors in adults16.

Lutathera (lutetium (177Lu) oxodotreotide) is also approved in Europe for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults3.

Important Safety InformationLUTATHERA(lutetium Lu 177 dotatate) is a prescription medicine used to treat adults with a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut.

LUTATHERA is associated with some serious safety considerations, and in some cases these may require a healthcare provider to adjust or stop treatment. Treatment with LUTATHERA will expose patients to radiation which can contribute to long-term radiation exposure. Overall radiation exposure is associated with an increased risk for cancer. The radiation will be detectable in urine for up to 30 days following administration of the drug. It is important to minimize radiation exposure to household contacts consistent with good radiation safety practices as advised by your healthcare provider. Treatment with LUTATHERA increases the risk of myelosuppression, a condition in which bone marrow activity is decreased, resulting in a drop in blood cell counts. You may experience blood-related side effects such as low red blood cells (anemia), low numbers of cells that are responsible for blood clotting (thrombocytopenia), and low numbers of white blood cells (neutropenia). Speak with your healthcare provider if you experience any signs or symptoms of infection, fever, chills, dizziness, shortness of breath or increased bleeding or bruising. Other serious conditions that you may develop as a direct result of treatment with LUTATHERA include blood and bone marrow disorders known as secondary myelodysplastic syndrome and cancer known as acute leukemia. Your healthcare provider will routinely check your blood cell counts and tell you if they are too low or too high. Treatment with LUTATHERA will expose kidneys to radiation and may impair their ability to work as normal. You may be at an increased risk for kidney problems after LUTATHERA treatment if you already have kidney impairment before treatment. In some cases, patients have experienced kidney failure after treatment with LUTATHERA. Your healthcare provider will provide you with an amino acid solution before, during, and after LUTATHERA to help protect your kidneys. You should stay well hydrated before, during, and after your treatment. You should urinate frequently during and after administration of LUTATHERA. Your doctor will monitor your kidney function and may withhold, reduce, or stop your LUTATHERA treatment accordingly. In clinical studies of LUTATHERA, less than 1% of patients were reported to have tumor bleeding (hemorrhage), swelling (edema) or tissue damage (necrosis) to the liver. If you have tumors in your liver, you may be more likely to experience these side effects. Signs that you may be experiencing liver damage include increases in blood markers called ALT, AST and GGT. Your healthcare provider will monitor your liver using blood tests and may need to withhold, reduce, or stop your LUTATHERA treatment accordingly. During your treatment you may experience certain symptoms that are related to hormones released from your cancer. These symptoms may include flushing, diarrhea, difficulty breathing (bronchospasm), and low blood pressure (hypotension), and may occur during or within the 24 hours after your first LUTATHERA treatment. Your healthcare provider will monitor you closely. Speak with your healthcare provider if you experience any of these signs or symptoms. Tell your healthcare provider if you are pregnant. LUTATHERA can harm your unborn baby. Females should use an effective method of birth control during treatment and for 7 months after the final dose of LUTATHERA. Males with female partners should use an effective method of birth control during treatment and for 4 months after the final dose of LUTATHERA. You should not breastfeed during treatment with LUTATHERA and for 2.5 months after your final dose of LUTATHERA. Treatment with LUTATHERA may cause infertility. This is because radiation absorbed by your testes or ovaries over the treatment period falls in the range of exposure where temporary or permanent infertility may occur.

The most common and most serious side effects of LUTATHERA include: vomiting, nausea, decreased blood cell counts, increased liver enzymes, decreased blood potassium levels, and increased blood glucose. Talk to your doctor if you experience any of these, or any other side effects.

Tell your healthcare provider if you are taking any other medications. Somatostatin analogs and corticosteroids may affect how your LUTATHERA treatment works. You should stop taking your long-acting somatostatin analog at least 4 weeks before LUTATHERA treatment. You may continue taking short-acting somatostatin analogs up to 24 hours before your LUTATHERA treatment. Avoid repeated high doses of glucocorticosteroids during treatment with LUTATHERA.

Please see fullPrescribing Informationfor LUTATHERA.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "seek," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Advanced Accelerator Applications S.A. Advanced Accelerator Applications, S.A. (AAA), a Novartis company, is developing targeted radioligand therapies and precision imaging radioligands for oncology indications. We are committed to transforming patients' lives by leading innovation in nuclear medicine. AAA has a legacy as a leader in radiopharmaceutical drugs for Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging. For more information, please visit: https://www.adacap.com

About NovartisNovartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com

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CRANFORD, N.J., May 25, 2021 /PRNewswire/ --Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that it has received the Best Poster Award at the prestigious International Society for Cell and Gene Therapy (ISCT) 2021 Annual Meeting.

The poster, titled "Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep," will be presented today, May 25, 2021 by Dr. Perenlei Enkhbaatar, Professor and Director of the Translational Intensive Care Unit at The University of Texas Medical Branch.

"The ISCT annual meeting brings together the brightest minds in cell and gene therapy and highlights cutting edge research in the field," stated Dr. Myron Czuczman, Chief Medical Officer and Executive Vice President of Citius. "We are honored to be selected for the Best Poster Award from among this distinguished peer group. The interim results demonstrate a marked improvement in i-MSC treated animals over control animals in key clinical parameters including: improved oxygenation, less systemic shock, and reduced bacterial burden and vascular injury to the lungs. We are encouraged by the data and welcome the support and engagement of the scientific research community," concluded Dr. Czuczman.

Myron Holubiak, President and Chief Executive Officer of Citius added, "We are grateful to be recognized by our peers for this award as we advance our novel stem cell program for the treatment of ARDS. In parallel to the expansion of our proof-of-concept ARDS sheep study, we are following guidance from the U.S. Food and Drug Administration (FDA) in the development of a cGMP Master Cell Bank of i-MSCs. I am pleased to report that we have completed the development of an i-MSC Accession Cell Bank (ACB) which is to serve as the basis for a scalable cGMP compliant manufacturing capability to support all of our planned pre-clinical and clinical trials. Compared with donor-derived cells that require a continuous supply of new donors, we believe our i-MSCs,derived from a single clonal induced pluripotent stem cell (iPSC), offer multiple advantages including consistent and scalable manufacturing and a potentially limitless supply of i-MSCs to meet our future needs. Moreover, we believe that our i-MSC stem cell program has the potential to meaningfully impact the treatment of ARDS and we appreciate the recognition received from the cell and gene therapy community as we advance our program."

Citius' i-MSCs are derived from iPSCs originating from a qualified single-donor dermal fibroblast, resulting in one homogeneous, validated source for all future cells. A patented synthetic, non-immunogenic mRNA high efficiency cell reprogramming technique is applied to create a clonal iPSC Master Cell Bank from which our i-MSCs are differentiated and expanded to create an i-MSC Accession Cell Bank. Citius has completed the development of its i-MSC ACB and is currently testing (as per FDA guidance) and expanding the cells to create an allogeneic cGMP i-MSC Master Cell Bank to support all future i-MSC needs.

The poster will be available to conference attendees via the conference website. The poster will be available on Citius' website once the event commences.

Conference Details:

Abstract Title:

"Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep"

Authors:

K. Hashimoto, N. Bazhanov, P. Enkhbaatar, M. Angel, A. Lader, M. Czuczman, and M. Matthay

Abstract Number:

100

Date and Time:

May 25, 2021

Session I

12:30 2:00 PM EDT

Session II

8:00 9:30 PM EDT

About Acute Respiratory Distress Syndrome (ARDS)

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability. ARDS is a frequent complication of patients with COVID-19. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Citius Pharmaceuticals, Inc.

Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapy. The Company's lead product candidate, Mino-Lok, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal superiority trial. Mino-Lok was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. For more information, please visit http://www.citiuspharma.com.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks relating to the results of research and development activities, including those for our NoveCite stem cell therapy; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our dependence on third-party suppliers; our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our need for substantial additional funds; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to attract, integrate, and retain key personnel; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our ability to procure cGMP commercial-scale supply; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at http://www.sec.gov, including in our Annual Report on Form 10-K for the year ended September 30, 2020, filed with the SEC on December 16, 2020 and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Investor Relations for Citius Pharmaceuticals:

Andrew ScottVice President, Special ProjectsT: 908-967-6677 x105E: [emailprotected]

Ilanit AllenVice President, Corporate Communications and Investor RelationsT: 908-967-6677 x113E: [emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

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Founded to meet the future protein demands of an expanding global population, Australias Magic Valley is developing cell-cultured lamb products including mince, strips, steaks and chops. With lambs currently slaughtered at an incredibly young age using traditional farming methods, its founder tells us this particular meat became the obvious choice for the companys first product range.

There is absolutely no need for the mass slaughter of animals for food and hopefully intensive animal agriculture will soon be a thing of the past

Vegconomist spoke with Founder Paul Bevan, who says that he had become frustrated by the pace of change and effectiveness of his own activism so he turned his attention to technology, specifically the development of slaughter-free cultured meat, beginning with lamb.

Utilising induced pluripotent stem-cells and FBS-free media, Magic Valley is able to grow real animal meat from animal cells, using animals such as Lucy, who Paul refers to as cell volunteers.

Eventually we would like to expand into developing cultured meat products for all other animal species

Lucy the lamb is our very special cell donor. From just a tiny skin biopsy less than 4mm in diameter we are able to generate an infinite number of muscle and fat cells without ever having to interfere with an animal again. That is one of the distinct advantages of our technology and using induced pluripotent stem cells.

Meanwhile, Lucy gets to live out the entirety of her natural life (up to 20 years of age) happy and unharmed, blissfully unaware that her cell donation has potentially saved the lives of billions of lambs that would otherwise have been slaughtered at just 6 months of age.

Magic Valleys team consisting of Australias leading scientists have extensive experience in both stem cell biology and livestock production. As part of its ambitions to become a leader in the field, the company also announced this week the onboarding of industry pioneer Dr. Sandhya Sriram, PhD, Co-Founder & CEO of the cell-based crustacean producers Shiok Meats, to its advisory board.

Eventually we would like to expand into developing cultured meat products for all other animal species that have traditionally been farmed for human consumption. With the advancement of this technology, there is absolutely no need for the mass slaughter of animals for food and hopefully intensive animal agriculture will soon be a thing of the past, Bevan commented to vegconomist.

Our immediate goal is to develop the safest, healthiest and tastiest cultured lamb products possible. We know that to be successful, cultured meat products have to become the obvious choice for consumers and that means taste, price & convenience are paramount. We know that ethical or environmental concerns alone are not enough to change consumer behaviour it has to be a better product.

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Australia's Magic Valley On How to Turn Cells From "Cell Volunteer" Lucy the Lamb Into Lamb Steaks and Chops - vegconomist - the vegan...

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Scientists in Japan from fiscal 2023 will applytechnology to createinduced pluripotent stem (iPS) cells to solve the mystery of how people age, saidNobel laureate Shinya Yamanaka, urging the government to continue funding regenerative medicine research.

Yamanaka,who was awarded the 2012 Nobel Prize in Physiology or Medicine jointly with Sir John B. Gurdon,called for continuous investments in the research of technologies based on iPS cells, such as one to rejuvenate aged cells.

The director of Kyoto Universitys Center for iPS Cell Research and Application (CiRA) made the appeal at a meeting of the science and technology ministry on May 11 to discuss governmental support for projects using iPS cells.

He also noted that research institutes and business operators need to boost their cooperation to realize a seamless flow from basic research through commercialization for the development of regenerative medicines.

The point is whether we can harness the total strength of Japan, Yamanaka said.

Yamanaka explained the center's research plans for fiscal 2023 and later, and stressed the essentiality of financial assistance to maintain Japans international competitiveness in the fields on which iPS cell researchers are expected to concentrate.

The government is pouring as much as 110 billion yen ($1 billion) over the 10 years from fiscal 2013 through 2022 into regenerative medicines taking advantage of primarily iPS cells.

As the support plan for 2023 or afterward has yet to be determined, the ministry in March started discussions over the issue.

Yamanaka said the technology to create iPS cells will be applied to ascertain the mechanism of how people age, starting from fiscal 2023.

Genes are injected into skin and blood cells to initialize them so that iPS cells obtain the ability to turn into other cells again. Improving the method is anticipated to be used to stop cells from aging and rejuvenate tissues.

Yamanaka also expressed his intention to make treatments using iPS cells common. Under the plan, the quality, uniformity and costs of iPS cells produced and supplied by the CiRA Foundation will be further improved.

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Nobel laureate calls for research funds to solve the mystery of aging : The Asahi Shimbun - Asahi Shimbun

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CHICAGO, May 25, 2021 /PRNewswire/ -- In-depth analysis and data-driven insights on the impact of COVID-19 included in this global regenerative medicine market report.

The regenerative medicine market is expected to grow at a CAGR of over 30% during the period 20202026.

Key Highlights Offered in the Report:

Key Offerings:

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Regenerative Medicine Market Segmentation

Regenerative Medicine Market by Application

Regenerative Medicine Market by Product

Regenerative Medicine Market by End-Users

Regenerative Medicine Market Dynamics

Regenerative medicine is expected to evolve and impact the overall healthcare industry in a positive way in the coming years. Among the global pharmaceutical companies, nearly 1000 companies are working on gene therapy, cell therapy, and tissue-engineering therapeutic products. Many companies worldwide have been developing a wide array of scaffolds that can be used in different tissue engineering applications, which cater to patients who require tissue and organ substitutes. The advances in scaffolds are attributable to several innovations in tissue scaffolds, bone scaffolds, and dental scaffolds. Tissue scaffolds basically act by integrating local cells in the desired shape of the scaffold after implantation. The scaffolds are of different types, such as cellusponge scaffolds in which cells are distributed in sponge pores and start growing. Collagen scaffolds have a unique porous network that allows diffusion of nutrients for cell growth, while hydrogel scaffolds have water content similar to natural tissue. Nanofiber scaffolds are transparent and ease cell imaging and quantification of cells.

Key Drivers and Trends fueling Market Growth:

Regenerative Medicine Market Geography

In 2020, North America accounted for a share of over 62% in the global regenerative medicine market. The region is expected to grow at a significant rate during the forecast period due to the highest number of RM companies in the world. The region has nearly 534 of the 987 RM companies worldwide. The growth is primarily attributable to the increasing incidence rates of different types of cancers such as non-Hodgkin lymphoma, Hodgkin lymphoma, melanoma of the skin, leukemia, and rare disorders, including Spinal muscular atrophy and multiple sclerosis. Cancer is the leading cause of death in North America. In 2018, nearly 1.9 million new cancer cases were reported in the North American region, along with 693,000 deaths. In the North American region, the US shows the highest prevalence rate for cancers such as non-Hodgkin lymphoma and other life-threatening rare diseases.

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Regenerative Medicine Market by Geography

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We offer comprehensive market research reports on industries such as consumer goods & retail technology, automotive and mobility, smart tech, healthcare, and life sciences, industrial machinery, chemicals and materials, IT and media, logistics and packaging. These reports contain detailed industry analysis, market size, share, growth drivers, and trend forecasts.

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Regenerative Medicine Market Size to Reach Revenues of over USD 27 Billion by 2026 - Arizton - PRNewswire

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