In 2018, the floor fell out beneath Protagonist Therapeutics. Months ahead of an expected readout, the companys first major trial, a Phase IIb testing their lead drug in ulcerative colitis, failed a futility analysis. Investors sold off en masse. Protagonist searched for answers.

Two years later, CEO Dinesh Patel maintains the drug had efficacy pointing to a blinded re-read conducted later that year but the company has moved on. Now, armed with the results from a small proof-of-concept, they are readying to put their resources behind a new lead program and another attempt at a pivotal trial in an entirely different disease.

We couldnt have asked for better data, Patel toldEndpoints News.

The drug is an artificial protein called PTG300. Unlike the drug in the 2018 trial or a compound licensed in 2017 to J&J, PTG-300 is designed to treat blood disorders. Since August, the company has been testing it in a series of tiny proof-of-concept trials to see how well it works in different diseases, including beta thalassemia, hereditary hemochromatosis and myelodysplastic syndromes.

The latest study, announced today, is in people with polycythemia vera, a chronic blood cancer in which patients produce an overabundance of red blood cells. Complications can range from itchiness to blood clots. Normally, patients are treated with phlebotomies every few weeks or months. The problem, though, is that their red blood cell counts can rise in-between and continually removing a persons blood is not without consequence. It can lead to weakness and iron deficiency, among other complications.

In the part of the trial that is now evaluable, investigators gave different doses of PTG-300 to 7 different patients who had at least three phlebotomies in the 24 weeks prior. Six patients did not need a phlebotomy over the 4 to 28 weeks they took it. A 7th had an unintended interruption to his dosing, received a single phlebotomy and continued therapy.

Lead investigator Ron Hoffman, called it a potential paradigm shift. Unlike phlebotomies or the other drugs used to treat the disease, it could allow patients to maintain good red blood cell counts over long stretches without severe side effects.

What has been done for 100 years is that patients undergo blood letting essentially, Hoffman told Endpoints. We didnt anticipate using this kind of approach. Its really pretty cool actually, Im excited.

The drug mimics the effect of hepcidin, a natural hormone that regulates iron levels. Because the body needs iron to produce red blood cells, limiting those levels can in theory limit overproduction in these patients.

The results convinced Protagonist to pick their lead indication ahead of schedule, Patel said. They will now expand their current study from a goal of 30 patients to 50 patients and they plan to start a pivotal trial next year. That will move it significantly ahead of their remaining irritable bowel disease asset, PTG-943. Development of that drug has been pushed back significantly during the Covid-19 pandemic; because it targets IL-23, it could make patients more susceptible to infection.

These are immuno-suppressive agents at the end of the day, Patel said of PTG973. Basically, for now the focus is on blood disorders.

Its a marked shift for Patel and Protagonist. The company spent a decade building its peptide-based platform, and its earliest assets were for IBD. They raised investors confidence around PTG100 and quickly brought it into a Phase IIb study. J&J offered $990 million in a deal centered on a second IBD drug, PTG-200. These drugs appealed particularly because they were oral, unlike the injectables that have dominated the inflammatory disorders market.

The J&J drug is still in the clinic, but in March of 2018, Protagonist announced that PTG-100 failed a futility analysis; an independent review board determined it had no chance of beating placebo. The stock fell 58%, from $20.43 to $8.59, roughly where it sits today.

PTG-100 has since been retired, but Patel claimed the review decision was actually wrong. The company noted a high placebo response in the initial assessment and sent it for a blinded review to a third party and CROs subcontractor, who determined some of the initial endoscopes had been initially misread and the trial should have continued.

Within two days we figured out the endoscopy readouts were errant, he said. The outcome should not have been futile.

The company went back to the FDA with the third party review, Patel said, but the FDA said they had to start a new trial. By that point, though, the company had already come up with PTG-943, which they believed worked better and was wiser to advance if they were going to start a new trial.

Now with Covid-19 pushing back IBD further, blood disorders have become the companys main strategy, despite having only a tiny, open-label data set. Patel is confident, though, that it can be a fruitful one. He said there was a clear regulatory path with a 150-person trial, good effects in those patients, and a significant potential market.

It fits all of the three category: strong data, a good regulatory path forward, and a very large commercial opportunity, he said. So thats where Protagonist will be focused.

Read more:
Two years after a wrenching setback, Protagonist touts a slice of data and sets sights on pivotal trial in a surprising place: the blood - Endpoints...

Recommendation and review posted by Bethany Smith

SOUTH SAN FRANCISCO May 8, 2020 (Thomson StreetEvents) -- Edited Transcript of CytomX Therapeutics Inc earnings conference call or presentation Thursday, May 7, 2020 at 9:00:00pm GMT

CytomX Therapeutics, Inc. - Senior VP & CFO

* Christopher S. Keenan

CytomX Therapeutics, Inc. - VP of IR & Corporate Communications

* Sean A. McCarthy

CytomX Therapeutics, Inc. - Chairman, CEO & President

* Biren N. Amin

* Christopher N. Marai

Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology

H.C. Wainwright & Co, LLC, Research Division - Associate

* Terence C. Flynn

Good day, ladies and gentlemen, and welcome to the CytomX Therapeutics First Quarter 2020 Financial Conference Call. (Operator Instructions)

As reminder, this call may be recorded. I would now like to introduce your host for today's conference, Christopher Keenan, Vice President of Investor Relations. Chris, you may begin.

Christopher S. Keenan, CytomX Therapeutics, Inc. - VP of IR & Corporate Communications [2]

Good afternoon, and thank you for joining us. Earlier today, we issued a press release that includes a summary of our recent progress and our first quarter 2020 financial results. This press release and a recording of this call can be found under the Investors and News section of our website at cytomx.com.

With me today are CytomX President, Chief Executive Officer and Chairman, Dr. Sean McCarthy; and CytomX's newly appointed Chief Financial Officer, Carlos Campoy.

During today's call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov, including our Form 10-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise.

I will now turn the call over to Sean.

Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [3]

Great. Thanks, Chris, and good afternoon, everybody. Thanks for your patience as we were getting the call up and running. I gather there's quite a lot of call volume at the moment.

Anyhow, once again, good afternoon, and thanks for joining us. It's a pleasure to be here to provide an update on our progress during the first quarter of 2020. I'll begin today's call with a brief overview of our business operations against the backdrop of COVID-19. And then, we'll review first quarter highlights across the pipeline. I'll then turn the call over to Carlos, our new CFO, you just heard off from Chris, and Carlos will review our first quarter and financial results, and I'll wrap up. And then open the call up for questions.

Let me start by saying that all of us at CytomX hope that you and your families are well and keeping safe during the ongoing pandemic. The situation is impacting all of us in different ways, and it looks like it will continue to do so for some time. We are committed to ensuring the continued well-being of those involved with the conduct of our business. This includes the patients, the staff, physicians engaged in our clinical trials, the vendors and partners who support these trials and, of course, our dedicated employees who continue to impress with their drive and focus during these challenging times.

Despite the operational challenges presented by COVID-19, our team remains highly focused and very mindful that as the American Cancer Society has recently reminded us all, cancer is not waiting, and so neither are we.

At CytomX, we see a major opportunity to more effectively target therapeutic antibodies into disease tissues, generating new classes of anti-cancer therapies. We believe our unique Probody therapeutic platform represents a fundamental advance in the field of antibody engineering, and we are highly focused on using our platform to discover and develop a broad clinical pipeline of novel drug candidates to make a meaningful difference in the treatment of cancer. Our unique science offers the potential for new and highly effective anticancer therapies, including first-in-class molecules against novel undruggable targets, potentially best-in-class molecules against validated targets and new combination therapies.

Probody is our fully recombinant antibody prodrugs comprised of a therapeutic antibody and a mask designed to block the binding of the antibody to its target until the mask is removed. Mask removal is achieved specifically and selectively within cancer tissue by certain disease associated proteins called proteases that we know are present and active in most cancers. Proteases are in effect molecular scissors, which in the context of tumor progression, function to cut a path for invading and metastasizing cancer cells. Our Probody strategy is to leverage tumor proteases to localize antibody activity into cancer tissue, thereby decreasing target engagement in normal tissues and broadening or even creating a therapeutic window.

We have pioneered this new approach, that we believe has the potential to improve and optimize a range of antibody formats, including cancer immunotherapies, antibody drug conjugates and T-cell engaging bispecific antibodies.

Despite the emergence of COVID-19, we had a very productive and important first quarter towards the ongoing advancement of our strategy of developing innovative cancer therapies in areas of significant unmet medical need and with a particular emphasis on undruggable targets.

I'd like to start today's update with CX-2009, our wholly-owned Probody drug conjugate that targets the previously undruggable target CD166. CD166 is a tumor antigen that's expressed a high levels on most solid tumors, but it's also present on most normal tissues, ruling it out as a target for a conventional antibody drug conjugate. Our previously presented data from Phase I dose escalation in various solid cancers has shown CX-2009 to be well tolerated and clinically active as monotherapy at doses of 4 mgs per kg and above. This dose is the threshold of which drug conjugates comprising the DM4 payload, the warhead on CX-2009 have been shown by others to be active in the clinic.

Clinical activity was observed in breast, head and neck and ovarian cancers with CX-2009, and we will be presenting updated data from Phase I dose escalation for this agent at ASCO in a couple of weeks.

In the fourth quarter of 2019, we announced the initiation of a Phase II expansion study of CX-2009 monotherapy in patients with hormone receptor positive HER2-negative breast cancer at a dose of 7 mgs per kg administered every 3 weeks, with the objective of enrolling up to 40 patients. Enrollment was initiated and patients were treated during Q1, but regressively, the COVID-19 situation led us to temporarily pause new patient enrollment and new site activation in this study. Our team continues to closely monitor emerging health authority guidance at IRB/Ethics Committee recommendations and our goal is to resume the CX-2009 clinical program as soon as practical.

Now staying with the theme of undruggable targets, I'd now like to turn to CX-2029,a CD71 targeting Probody drug conjugate that we're developing in partnership with AbbVie, and for which, in Q1, we announced the achievement of a major collaboration milestone.

Long considered a high potential but undruggable antibody drug conjugate target, CD71 is known as a professional internalizer, given its role of moving iron from the extracellular space into intracellular compartments. And it does this in all dividing cells. In fact, many consider CD71 to be the gold standard internalizer to assess the in vitro activity of antibody drug conjugates.

But the presence of CD71 on normal cells has been an impediment to its use as a drug target. CX-2029 is a Probody against CD71, conjugated to the cytotoxic payload MMAE. We recently announced the achievement of prespecified dose escalation success criteria for the CX-2029 Phase I dose escalation study, resulting in a $40 million milestone payment from AbbVie to CytomX. Data from this Phase I study will be the subject of an oral presentation at ASCO 2020.

The CytomX and AbbVie teams are now actually finalizing plans for the initiation of Phase II expansions as soon as possible. CytomX has the responsibility for advancing this program through initial proof of concept, whereupon, if successful, the program will transition to AbbVie for registrational studies and ultimate commercialization. CytomX retained significant U.S. commercial rights to this asset and is also eligible to receive double-digit ex U.S. royalties, should the product reach the market.

I'd now like to move to another unique R&D strategy that we're pursuing at CytomX, which is to use our Probody technology to generate first-in-class agents against undruggable targets in the context of T-cell engaging bispecific antibodies, which I will refer to, going forward as, TCBs. TCBs are highly potent therapeutics, which directs the activity of cytotoxic T-cells to tumors. This approach has the potential to take immunologically cold tumors and make them hot, opening many new avenues for cancer treatment. While clinical advances have been made with this approach in hematologic malignancies, notably with Amgen's CD19 CD3 bispecific Blincyto. Its application in solid tumors has been challenging. The reason for this is that the high potency of TCBs can target normal tissues with low antigen expression, resulting in significant toxicities.

For several years, we've been working at CytomX to research and optimize the Probody or masked versions of TCBs with an initial focus on the EGFR-CD3 target pair. Data published by others has shown that EGFR, whilst the well-validated oncology target is undruggable in the context of a CD3 bispecific, a conventional CD3 bispecific.

After this preclinical findings have shown that Probody TCBs against EGFR could induce tumor regressions and create a therapeutic window for this cancer target. These important findings served as the foundation for our ongoing collaboration with Amgen, which I'll speak about in just a few moments.

Building on our successful research on Probody TCBs, during Q1, we announced a major strategic collaboration in this area with Astellas. Under this new agreement, CytomX and Astellas will collaborate on 4 initial programs focused on the discovery, research, development and commercialization of Probody TCBs targeting undisclosed tumor antigens for the treatment of cancer. CytomX will lead early drug discovery activities with Astellas leading preclinical and clinical development and commercialization activities. Under the terms of the agreement, CytomX received an $80 million upfront payment and is eligible to receive future preclinical, clinical and commercial milestones of over $1. 6 billion, together with tiered royalties on product sales that range from high-single digits into the mid-teens.

For certain targets, CytomX may co-fund a predetermined portion of product development costs and become eligible to receive a prespecified portion of profits in the United States. CytomX may also later elect to co-commercialize products directed towards such targets in the U.S. Research work and the collaboration is underway, and we are thrilled to have Astellas as our newest partner.

Returning now to our Amgen partnership. I'm also delighted to report that we have recently advanced a lead Probody TCB candidate against EGFR that we call CX-904 into IND-enabling studies. This is the first pro TCB from our platform to reach this important landmark. CytomX is responsible for IND filing, which is targeted for late 2021 and for early clinical development. We're very pleased with this excellent scientific progress with our Amgen alliance and with the growing excitement around the potential of the Probody TCB space, as also evidenced by our new partnership with Astellas.

Moving now to our potential best-in-class programs, CX-072, our wholly-owned anti-PD-L1 Probody and BMS-986249, the anti-CTLA-4 Probody partnered with Bristol Myers Squibb.

The CX-072 was the first Probody we advanced into the clinic, and it has provided us with crucial insights and the first clinical proof-of-concept for our platform. We'll be presenting long-term follow-up data from the CX-072 Phase I/II study as an oral presentation at ASCO.

In Q1, as part of our portfolio reprioritization, we announced the termination of the Phase II program combining CX-072 with ipilimumab, the anti-CTLA-4 antibody in patients with relapsed or refractory melanoma. This decision followed a reevaluation of the evolving clinical competitive and commercial landscape in immuno-oncology, taken together with the impact of the COVID-19 pandemic. We continue to evaluate opportunities for the further advancement of the CX-072 program and we plan to initiate combination studies with our second wholly-owned program CX-2009 later this year.

During Q1, we also announced an important pipeline milestone in our foundational oncology collaboration with BMS. The leading edge of this alliance is the anti-CTLA-4 Probody BMS-986249.

CTLA-4, the target of ipilimumab, is the prototypical checkpoint target, and blocking this mechanism has proven highly effective in the treatment of patients with melanoma and other cancer types, both as monotherapy and in combination with PD-pathway inhibitors. While a very important advance, CTLA-4 blockade can cause severe immune-related toxicities, creating a clear opportunity for a Probody version of this agent to improve tolerability, increased duration of treatment and potentially improved activity. BMS and CytomX have previously presented preclinical proof-of-concept for CTLA-4 Probodies at several major research conferences and Phase I clinical data for this Probody will be presented at ASCO.

Based on these Phase I findings, BMS recently initiated a randomized Phase II expansion study comparing the tolerability and activity of BMS-986249, plus nivolumab, to ipi plus nivo in frontline metastatic melanoma. The advancement of the CTLA-4 Probody into this study triggered a milestone payment of $10 million from BMS to CytomX.

This is an important study, that if positive, has the potential to place the ipilimumab Probody on a registrational path.

Moreover, this work is a terrific example of what we set out to do with our platform when it was first conceived of, and we're excited about its potential for cancer patients.

Additional recent progress within our BMS alliance includes the initiation of the dose escalation phase of another clinical study, a Phase I/II study for a second anti-CTLA-4 Probody. We call this BMS-986288. And this is based on a modified version of ipi.

The second clinical Probody program demonstrates BMS' ongoing commitment to our technology platform as a way to potentially unlock additional value in the CTLA-4 mechanism and across other targets.

Before handing over to Carlos, I want to also note that we continue to strengthen our executive leadership at CytomX and with the appointments in Q1 of Carlos, our CFO; and also Dr. Alison Hannah as Chief Medical Officer. Carlos and Alison bring -- each bring over 30 years of leadership experience from across their respective domains, and we are absolutely delighted to welcome them to the team.

I would now like to turn the call over briefly to Carlos.

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Carlos Campoy, CytomX Therapeutics, Inc. - Senior VP & CFO [4]

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Thank you, Sean. I'm very pleased to be here. I'd like to review the financial highlights for the first quarter ending March 31, 2020. Revenue for the quarter was $50 million compared to $29 million in the corresponding period in 2019. The increase was primarily due to the partial revenue recognition of the $40 million milestone earned from AbbVie associated with the CX-2029 project and $10 million related to the milestone earned from BMS associated with the initiation of the Phase II randomized cohort expansion of BMS-986249.

Research and development expenses were $43 million for the quarter compared to $36 million in the corresponding period in 2019. The increase was largely attributed to license and sublicense fees associated with milestones and upfront payments earned in the first quarter of 2020.

General and administrative expenses were flat compared to the corresponding period in 2019. We ended the quarter with cash, cash equivalents and investments totaling $247.9 million compared to $296.1 million as of December 31, 2019.

Our achievements in existing and new partnerships during Q1 have resulted in $130 million in milestone and upfront payments to CytomX that are not reflected in our end of Q1 cash balance. I would like to underscore the company's continued strong track record of executing strategic business development transactions to broaden our pipeline and access additional non-dilutive operating capital. We expect our strong balance sheet to allow us to comfortably meet projected operating requirements into the second half of 2022, assuming no new collaborations or financings.

With that, I'll turn the call back to Sean.

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Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [5]

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Great. Thanks, Carlos.

So to wrap up, CytomX had a very strong first quarter of 2020, with many key achievements across our preclinical and clinical programs in our existing partnerships and in the formation of a major new strategic alliance. We have a strong balance sheet to advance our pipeline and weather market uncertainty. And we're looking forward to ASCO, of which we have multiple presentations that will provide important updates on all of our clinical stage programs. I am very proud of the CytomX team for staying intensely focused in these challenging times, as we drive towards making the biggest difference we can for patients with cancer.

So thanks all for your time today. We wish the very best to you and your families. And Chris, please now open the call up to questions.

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Christopher S. Keenan, CytomX Therapeutics, Inc. - VP of IR & Corporate Communications [6]

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Operator, we'll take our first question.

================================================================================

Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Peter Lawson with Barclays.

Our next question comes from Peter (sic) [Chris] Marai with Nomura Instinet

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [2]

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CD166 -- Can you hear me okay?

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Operator [3]

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Yes, sir. You were muted in the beginning. You came on halfway.

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Christopher N. Marai, Nomura Securities Co. Ltd., Research Division - MD & Senior Analyst of Biotechnology [4]

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Okay. I'm sorry about that. So what I mentioned is the toxicity around the CD166 program versus the CD71. I'm just curious about the payloads being used here. And the internalization profiles of the targets, given that CD71 is very efficient in internalizing, does that impact the type of payload that you chose to use? I noticed that you 2 different payloads for these products.

Also for the CD71 PDC, I'm curious about what would some expected on target toxicities might look like versus toxicities due to the payload in general?

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Sean A. McCarthy, CytomX Therapeutics, Inc. - Chairman, CEO & President [5]

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Yes. Thanks for the questions. So first of all, with regards to the payloads, going back several years, when we designed the Probody drug conjugate strategy, we made a very conscious decision that the first 2 Probody drug conjugates to take into the clinic that we would work with, the most established warheads or payloads, if you like. And DM4 was selected for the CD166 program through an alliance with ImmunoGen and MMAE, which at the time was the second most validated payload. We were able to access that through our alliance with AbbVie via their alliance with Seattle Genetics. And so frankly, we could have used -- it could have ended up being the other way around. That's just the way it played out at the time. We considered those 2 payloads to be the most and best validated at that time.

In terms of the toxicities with DM4, we've known for a long time that the principal toxicity with DM4 is ocular tox. That's exactly what we saw at the higher doses in our dose escalation in Phase I, is something that is manageable in the form of ocular prophylaxis. So that's something that we're implementing in the ongoing Phase II study.

With regard to CD71 and MMAE, the principal toxicities with MMAE are a little bit different to DM4. They're more hematologic in nature. And that's what we saw in our preclinical studies and hematologic toxicities that we're looking out for in the clinic.

With regards to CD721 on target toxicity, it's very difficult to say. With CD166, just as an example, the target is expressed on most normal tissues and you could, therefore, infer that you may see toxicity of any kind. In fact, in the clinic, we really didn't see any evidence of on target toxicity with our reported data on CD166. We'll provide the data on CD71 Phase I dose escalation in a couple of weeks at ASCO.

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Operator [6]

Follow this link:
Edited Transcript of CTMX earnings conference call or presentation 7-May-20 9:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Prediabetes is when your blood sugar levels are high, but not high enough to be considered type 2 diabetes.

Since prediabetes usually doesn't come with symptoms, doctors recommend getting screened if you have certain risk factors.

Image Credit: FatCamera/E+/GettyImages

"It's sort of an in-between condition," says Sue Kirkman, MD, professor of medicine in the division of endocrinology and metabolism at UNC Health. "It's considered a precursor to type 2 diabetes."

Blood sugar levels that are between 100 and 127 mg/dL are considered prediabetes, according to the American College of Cardiology. Normal is between 70 and 100 mg/dL, and anything above 127 is considered type 2 diabetes.

About one-third of Americans have prediabetes, according to the Centers for Disease Control and Prevention (CDC), although the majority don't know it.

People who have been diagnosed with the condition have a 50 percent chance of moving on to full-blown type 2 diabetes within the next five to 10 years, according to the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK).

"If changes aren't made in eating habits and activity, many people with prediabetes will move into the diabetes category," Julie Stefanski, RDN, a dietitian, certified diabetes instructor and spokesperson for the Academy of Nutrition & Dietetics, tells LIVESTRONG.com.

Even if you don't develop diabetes, though, having prediabetes can up your risk of heart and kidney disease, per the Mayo Clinic.

If you know you have prediabetes, you have the opportunity to take measures to get your blood sugar levels down to a healthy range and prevent the condition from progressing.

Being overweight is a risk factor for prediabetes.

Image Credit: Zero Creatives/Image Source/GettyImages

The biological causes of prediabetes (and diabetes) have to do with insulin resistance.

Insulin is the hormone that guides blood sugar molecules (broken down from the food you eat) out of the bloodstream and into cells, where they're used as fuel. In prediabetes and diabetes, your body either loses the ability to respond properly to insulin or doesn't make enough insulin, which means the sugar levels in your blood build up.

"As prediabetes develops, the body struggles more and more to process certain foods," Stefanski explains. "The pancreas must make higher levels of insulin to take sugar out of the blood and put it into the cells of the body. Eventually the body won't be able to keep up with insulin needs and blood sugar levels will rise."

No one really knows what causes insulin resistance in the first place, though it seems to be a combination of factors.

"The risk factors for prediabetes are the same as risk factors for type 2 diabetes," Dr. Kirkman says. According to the Mayo Clinic, those include:

1. Family history and genetics: If you have a parent or sibling with type 2 diabetes, you're more likely to develop prediabetes (and type 2 diabetes).

2. Age: The risk of developing prediabetes rises after the age of 45.

3. Being overweight or obese: The risk is even greater if fat is concentrated around the abdomen.

4. Waist size: Men with waists larger than 40 inches around and women who have waist circumferences larger than 35 inches are at a higher risk for insulin resistance, even if their body mass index (BMI) is normal, according to the NIDDK.

5. Being inactive: Regular exercise is key to reaching and maintaining a healthy weight and helps your body better process sugar and use insulin.

6. Diet: Red and processed meat along with sugary beverages increase the risk of prediabetes. Eating more fruits, vegetables, whole grains, olive oil and nuts is linked to a lower risk.

7. Gestational diabetes: Women with a history of this pregnancy condition are at higher risk for prediabetes and type 2.

8. Race and ethnicity: African Americans, Hispanics, Native Americans, Asian Americans and Pacific Islanders have a higher risk than other groups.

9. Polycystic ovary syndrome: This hormonal disorder in women, commonly referred to as PCOS, is marked by small cysts on the ovaries, according to the Mayo Clinic.

10. Metabolic syndrome: This condition is marked by high blood pressure combined with abnormal cholesterol levels and a large waist size, per the NIDDK.

11. Other risk factors: Obstructive sleep apnea and smoking may increase insulin resistance. Certain medications and hormonal disorders can also put you at higher risk.

Extreme thirst is one sign of prediabetes.

Image Credit: fizkes/iStock/GettyImages

Like the early stages of diabetes, prediabetes usually doesn't have any symptoms at all. That's why some 90 percent of people with the condition don't even know they have it, Dr. Kirkman says.

Some people may have warning signs, which could include:

Because prediabetes usually doesn't have any symptoms, "it's important to get screening tests if you have risk factors," Dr. Kirkman says.

The American Diabetes Association (ADA) recommends testing be considered in adults who have no symptoms but have a BMI of 25 or higher (23 or higher in Asian Americans) and one or more other risk factors.

Testing should begin for all people starting at age 45. If your results are normal, you don't have to be re-tested for three years, Dr. Kirkman says.

The same three tests that can diagnose diabetes are also used to diagnose prediabetes, according to the Endocrine Society. They are:

1. Fasting blood glucose test (FBG): This is a blood test that takes place after you've been fasting for eight hours (usually overnight) and drinking only water. Prediabetes is when your fasting blood sugar is between 100 and 125 mg/dL, says Dr. Kirkman.

2. Hemoglobin A1c test (HbA1C): This test measures your blood sugar levels over the past three months. Prediabetes is indicated when your numbers are between 5.75 and 6.4 percent, says Dr. Kirkman.

3. Oral glucose tolerance test (OGTT): This test is rarely used, says Dr. Kirkman. That's partly because it's difficult to do. You have to have blood drawn two hours before and after drinking a sugary beverage, all after eight hours of fasting. A result over 140 means you are prediabetic, while over 200 indicates diabetes, per the NIDDK.

Typically, doctors will repeat the tests before giving a diagnosis of diabetes or prediabetes, says Dr. Kirkman.

Lifestyle changes like adding more activity to your days may help prevent prediabetes from turning into type 2 diabetes.

Image Credit: monkeybusinessimages/iStock/GettyImages

Treating prediabetes really means preventing type 2 diabetes, and the sooner you get started the better. The American Academy of Family Physicians (AAFP) notes that the longer you have either condition, the higher the likelihood you'll end up with health complications.

"The main goal is to not advance to the point where you have type 2 diabetes," Dr. Kirkman says. "The treatments are primarily losing weight and exercising or certain medication."

If you're overweight, losing just 5 to 7 percent of your body weight (or 10 to 14 pounds for a 200-pound person) can lower your risk for type 2 diabetes, according to the NIDDK. This will help push your blood pressure and cholesterol levels into healthy ranges, per the AAFP, and most importantly, adds Dr. Kirkman, "some people with weight loss will actually revert to having normal blood sugar."

There's debate about whether you can actually "reverse" prediabetes or even type 2 diabetes but, says Dr. Kirkman, with proper lifestyle changes, you can prevent or indefinitely delay progression.

The best way to lose weight is through diet and exercise, each of which bring their own benefits to the table.

When it comes to diet, there's no one right way to eat if you have prediabetes. One place to start, though, is in the timing of your meals.

"Start by cutting back on the portions of foods you're eating at one time," Stefanski says. "Rather than eating the majority of your food during a few hours at night, spread those choices out more so that the body doesn't have to process everything at the same time."

Did you know that keeping a food diary is one of the most effective ways to manage your weight? Download the MyPlate app to easily track calories, stay focused and achieve your goals!

You can also diminish portion sizes gradually, drink water rather than sweetened beverages and opt for whole fruit over fruit juice.

Green vegetables are a great way to feel full without raising your blood sugar, and the AAFP recommends eating more whole grains, lean proteins and low-fat dairy.

Foods to avoid include those that are processed, fried and sugary.

"No matter what your weight, it's important to become more physically active," Stefankski says. "We've worked regular activity out of our daily lives. As humans, we need to move and stay active to keep processes within the body working appropriately."

The CDC recommends aiming for at least 150 minutes of moderate physical activity each week. Brisk walking is a good option, as are swimming and bike riding.

Research shows that people who get support are more likely to achieve their goals. Indeed, those with prediabetes who enacted changes encouraged by the National Diabetes Prevention Program (DPP), which includes a support component, lowered their risk of developing type 2 diabetes by as much as 58 percent.

There's some controversy as to whether medications can or cannot help people with prediabetes. In one study, though, conducted as part of the DPP Outcomes Study, the medication metformin dropped the risk of developing type 2 diabetes by 31 percent. Ask your doctor if medication might be right for you.

See the article here:
What Is Prediabetes? Causes, Symptoms and Treatment - LIVESTRONG.COM

Recommendation and review posted by Bethany Smith

Boulder May 6, 2020 (Thomson StreetEvents) -- Edited Transcript of Clovis Oncology Inc earnings conference call or presentation Tuesday, May 5, 2020 at 8:30:00pm GMT

Clovis Oncology, Inc. - VP of IR

* Daniel W. Muehl

Clovis Oncology, Inc. - Executive VP & CFO

* Patrick J. Mahaffy

Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director

SVB Leerink LLC, Research Division - MD of Targeted Oncology & Senior Research Analyst

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Kennen B. MacKay

RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research

Thank you for standing by, and welcome to the Clovis Oncology First Quarter 2020 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I'd now like to hand the conference over to your speaker today, Anna Sussman, Vice President of Investor Relations. Thank you. Please go ahead.

Anna Sussman, Clovis Oncology, Inc. - VP of IR [2]

Thanks, Jessie. Good afternoon, everyone. Welcome to the Clovis Oncology First Quarter 2020 Conference Call. Thank you for joining us. You've likely seen this afternoon's news release. If not, it's available on our website. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks.

Today's agenda includes the following: Pat Mahaffy, our President and CEO, will discuss the key components and highlights of today's corporate update, including commentary about any potential impact related to COVID-19; then Dan Muehl, Clovis' Chief Financial Officer, will cover the quarter's financial results in greater detail; Pat will make a few closing remarks; and then we'll open the call for Q&A, during which time, Lindsey Rolfe, our Chief Medical Officer, will also be available to answer questions.

Before we begin, please note that during today's conference call, we may make forward-looking statements within the means of the federal securities laws, including statements concerning our financial outlook and expected business plans. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statements.

Now I'll turn the call over to Pat Mahaffy.

Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

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Thanks, Anna. Welcome, everybody. Appreciate you taking the time today. As we all know, the world has changed so much since our last quarterly update in late February. It's a complicated time for all of you, I know. Health care professionals have been and remain on the front lines of this global pandemic and I'd like to acknowledge the contributions of health care workers around the world, putting their lives on the line to care for those affected by COVID-19.

Closer to home, we'd also like to recognize the tremendous effort being made by our investigators and prescribers to maintain enrollment and safely manage ongoing patients in our clinical trials and for continuing to prescribe and manage Rubraca commercial patients during this period of significant upheaval to their clinics and practices.

I'll use our time today to discuss the highlights of the topics you've come to expect on our quarterly calls and focus on providing additional color on how we are navigating the COVID-19 world here at Clovis, and our view of how COVID-19 may affect oncology treatment going forward, and then we'll open it up for Q&A with Dan, Lindsey and myself.

Let's begin with a commercial update for Rubraca. I'm pleased to report that we had a very encouraging first quarter. Our global net revenue was $42.6 million. This represents an 8% sequential increase from Q4 2019 and 29% increase over Q1 2019. This was our best quarter of sales to date, despite the fact that reps had to begin staying home beginning in mid-March in the United States and could no longer call on health care providers in person for the last few weeks of the quarter. Also, our European launches in Italy, Spain and France are all occurring in an environment in which our field-based personnel have not been allowed to visit hospitals or clinics beginning in late February and are therefore also working from home.

Given these circumstances, we are very pleased with our sales growth in the first quarter. And now I'll share why we believe that Rubraca is well positioned as an oncology treatment option in the current acute COVID-19 era, and in the chronic COVID environment that is sure to follow. This period has been very disruptive for hospitals, clinics and patients as health care professionals are redirected, broadly described elective procedures are delayed and health care facilities are converted to support COVID-19 treatment efforts. We do believe that oncology will be among the first health care specialty to return to some normalcy so that likely means adapting to a new normal in a chronic COVID-19 world, one in which there is a focus on minimizing clinical visits to avoid risk to patients, especially cancer patients and other patients with known comorbidities.

It is also clear that cancer patients will need to be diagnosed and treated, given the evident risk in not actively managing their disease. We believe that Rubraca, a convenient oral therapy has significant advantages as a maintenance option in the recurrent ovarian cancer setting in an environment in, as I described, physicians are trying to reduce patient visits to their clinics. Unlike Avastin as a maintenance option that requires frequent infusions and weekly monitoring for hypertension, a known risk factor for COVID-19, Rubraca is an oral agent and is taken at home and only requires monthly routine monitor. Unlike observation, which on average leads to disease progression and requires a return to immunosuppressive chemotherapy after approximately 5 months, Rubraca has been shown to extend progression-free survival and therefore, subsequent chemotherapy, on average, nearly 14 months by independent assessment, nearly 3x longer than placebo. In fact, observation is an invitation to infusion. And unlike ZEJULA, which requires weekly blood monitoring for the first month, which obviously requires weekly visits to the clinic or a laboratory, Rubraca requires only monthly routine monitoring. As you can see, Rubraca offers numerous potential advantages in a chronic COVID-19 world, and we have already introduced a variety of new digital materials for our now home-based field personnel we use to engage with hospitals, clinics, doctors and pharmacies.

While we may see some near-term impact on revenues as physicians adapt their practices to COVID-19, we believe these advantages will remain over the course of this year and future years and as we all know, COVID-19 is not likely going away in the near term.

In addition to seeking to establish Rubraca as the maintenance treatment option of choice in recurrent ovarian cancer, we also look forward to the potential launch in the United States of Rubraca in advanced mutant BRCA prostate cancer, and that brings us to our most near-term development and regulatory program in this setting.

In November 2019, we submitted our planned supplemental new drug application, or sNDA for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutant recurrent, metastatic CRPC. The FDA filing was based on data from the TRITON2 clinical program in advanced prostate cancer. In the U.S., by the way, approximately 12% of men with metastatic CRPC have a mutation of BRCA1/2 in their tumor.

In January 2020, we announced that the FDA accepted our sNDA for Rubraca and granted priority review status to the application with the PDUFA date of May 15, 2020. Based on our interactions with the FDA, we have no reason to expect any delay to our May 15 PDUFA date. We think that Rubraca represents an important hormone-free and chemotherapy-free option for men with metastatic CRPC and a BRCA1/2 mutation. Recall that we've previously reported at ESMO last fall, a confirmed objective response rate of 44% by investigator and a confirmed PSA response of 52%. The safety data for men with CRPC were consistent with prior safety reports for patients with ovarian cancer and other solid tumors.

We've been engaged by -- encouraged by our interactions with both the medical oncology and urology communities about the potential for Rubraca to address the unmet medical need in recurrent metastatic CRPC. We are actively engaged in launch preparations, including sales force training that was completed in early March, and we will be ready to launch upon approval. Obviously, this will be among the first group of oncology launches that we'll incur entirely or almost entirely virtually. And we have taken considerable effort to prepare for this virtual launch. Our field sales team is prepared to initiate Zoom-based sales calls with prescribers, and will leverage learnings accumulated through their virtual selling efforts in the ovarian cancer setting since mid-March. All launch collateral for the sales team has been digitized to ensure they have the ability to utilize resources in virtual interactions. The promotional national broadcast has been fully converted to a virtual streaming program enabling HCPs to watch from any computer or iPad or any device in their office or home. Additional broadcast times have been added to ensure flexibility across all U.S. time zones. Program registration will be aided through targeted online advertising that will commence the day of approval. Media and advertising efforts have been weighted toward digital programming versus print to maximize impact and effectiveness of resources invested.

So to be clear, we will be ready to launch in prostate even in this new environment. Let me turn now to the clinical pipeline for Rubraca and lucitanib as well as our ongoing plans for FAP-2286. To begin, we are adhering to the regulatory guidance that FDA and other agencies have provided regarding clinical trial conduct during COVID-19, and our clinical teams are working closely with investigators to assure the safety of trial participants and investigators while maintaining compliance with good clinical practice and minimizing risk to the integrity of our trials.

While we did not see any material disruption to our clinical trials as a result of COVID-19 during the first quarter, it is possible that near-term effects may begin to emerge across different aspects of our clinical trial programs. For example, new patient recruitment in certain clinical studies may be affected, and the conduct of clinical trials may vary by geography as some regions are more adversely affected. I will note that we continue to anticipate completing enrollment in our largest study, the ATHENA frontline maintenance study before the end of this quarter. The LODESTAR study, our Phase II pan-tumor study to evaluate Rubraca in homologous recombination repair genes across tumor types continues to enroll patients. The study will evaluate Rubraca in patients with recurrent solid tumors associated with the deleterious homologous recombination repair or HRR gene mutation. Based on our interactions with FDA, this study may be registration-enabling for a targeted gene and tumor-agnostic label. If enrollment continues as planned, we could potentially file for approval in 2021.

Next, I'd like to briefly highlight our combination studies with BMS for both Rubraca and lucitanib, and then discuss our newest compound, 2286. We remain enthusiastic about our ongoing clinical collaboration with Bristol-Myers Squibb and I'll take a moment to review certain of our combination studies for both Rubraca and lucitanib with nivolumab. I'll begin with the Rubraca combinations.

FRACTION-GC is a BMS-sponsored multi-arm Phase II study evaluating the combinations of each of Opdivo and Yervoy with Rubraca as well as Opdivo, Yervoy and Rubraca in combination for the treatment of advanced gastric cancer. This is the first sponsored study to explore this triplet combination, and it is currently enrolling patients into the safety lead-in portion of the study. The Clovis-sponsored Phase III ATHENA trial in first-line maintenance for advanced ovarian cancer continues to enroll well, despite the COVID-19 environment. And as I noted, we continue to anticipate completing enrollment in this 1,000 patient study in the second quarter of 2020.

With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 outcomes as monotherapy versus placebo in the first-line maintenance setting in the HRD population, inclusive of BRCA and in the all-comers or intent-to-treat population as well as any potential advantage of the combination of Rubraca and Opdivo in the same patient populations. ATHENA is the first frontline switch maintenance study designed to show both PARP monotherapy and PARP/PD-1 combination therapy in one study design. I'll take a moment to remind you of the statistical analysis planned for ATHENA. First, expected in the second half of next year, we will see the results of Rubraca monotherapy versus placebo in all study populations. And then probably a year or more later, we will see the results of Rubraca plus Opdivo versus Rubraca in all study populations. In each of these analyses, we will first evaluate outcomes in the HRD population, including BRCA, and then step down to the entire intent-to-treat population.

To wrap up Rubraca and move to lucitanib, I'll described SEASTAR, our Clovis-sponsored Phase Ib/II study that includes multiple single-arm Rubraca combination studies, including the combination of Rubraca with sacituzumab govitecan, now known as Trodelvy for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and metastatic urothelial cancers. A separate arm of SEASTAR includes the combination of Rubraca with lucitanib in advanced solid tumors, which is currently in the dose-finding Phase Ib portion of the study.

Lucitanib, of course, is our investigational inhibitor of tyrosine kinases, including vascular endothelial growth factor receptors 1 through 3, platelet-derived growth factor receptors alpha and beta and fibroblast growth factor receptors 1 through 3. In February 2019, we and Bristol-Myers Squibb expanded our clinical collaboration to include planned combinations of Opdivo with lucitanib. The Clovis-sponsored LIO-1 study is a Phase Ib/II study evaluating lucitanib in combination with Opdivo. LIO-1 is now enrolling patients with advanced solid tumors in the Phase Ib portion of the study. We anticipate submitting abstracts for presentations at a medical meeting in the fall of 2020.

Lastly, the BMS-sponsored CheckMate 79X study is a Phase I/II study evaluating multiple combinations with Opdivo including an arm in combination with lucitanib in patients with second-line non-small cell lung cancer. Start-up activities for the CheckMate 79X study are proceeding for regulatory guidelines for clinical trial conduct during COVID-19.

We remain very enthusiastic about our peptide-targeted radiopharmaceutical therapy program, and in particular, our lead compound, FAP-2286. FAP is highly expressed in cancer-associated fibroblast or CAFs, which are found in the majority of cancer types, potentially making it a suitable target across a wide array of solid tumors. It is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas. Recent preclinical data in animal models, which we expect will be reported at an upcoming medical meeting, has only increased our optimism around this program.

In addition, we and 3BP are collaborating on a discovery program directed at 3 additional targets for radionuclide therapy, to which we have global rights. We've regone to this program for many reasons, including, of course, the opportunity to be a leader in the emerging field of targeted radiotherapy for the treatment of solid tumors. In this case, we have the opportunity to be the first to clinically develop an FAP-targeted radionuclide, and we are also enthusiastic about the targets of the subject of our planned -- or our ongoing discovery collaboration.

Clovis currently plans to submit an investigational new drug or IND application for FAP-2286 in the second half of 2020, followed by a Phase I study to determine the dose and tolerability of the FAP-targeting therapeutic agent with expansion cohorts planned in multiple tumor types as part of the global development program. Thus far, in radiotherapeutic development, physicians have used an imaging agent to identify patients with the appropriate level of tumor target, in our case, FAP. We are exploring opportunities to generate imaging data for FAP-2286, potentially even before our IND is submitted. Not only would this information be useful to gain additional experience with FAP-2286 and better understand the characteristics of FAP expression in multiple tumor types, but further will allow us to collaborate with other academic institutions eager to explore the potential of FAP-2286 as an imaging and as a treatment modality.

And with that, I'll turn the call over to Dan to discuss first quarter 2020 financial results.

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Daniel W. Muehl, Clovis Oncology, Inc. - Executive VP & CFO [4]

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Thanks, Pat, and hello, everyone. We reported net product revenue for Rubraca of $42.6 million for Q1 2020, which included U.S. net product revenue of $39.3 million and ex-U. S. net product revenue of $3.3 million. This represents a sequential increase of 8% over Q4 2019 net revenue of $39.3 million and a 29% increase over Q1 2019 net product revenue of $33.1 million. U.S. net product revenue was $39.3 million for the first quarter, up 9% from $36.1 million reported in Q4 2019 and up 23% from the $31.9 million reported in Q1 2019. The supply of free drug distributed to eligible patients in the U.S. through the Rubraca Patient Assistance Program for Q1 2020 was 12% of overall commercial supply compared to 18% in Q4 2018. This represented $5.6 million in commercial value for Q1 2020 compared to $8 million in Q4 2019. We can't yet predict the impact of COVID-19 and related unemployment on cap utilization over the remainder of 2020.

Ex-U. S. net product revenue was $3.3 million for the first quarter of 2020, which represents a slight increase over the $3.2 million reported for Q4 2019 and the $1.2 million reported in the first partial quarter of ex-U. S. sales in Q1 2019. We launched Rubraca in France and Spain during March 2020, so we only expected a small contribution in Q1 for those countries. We have now recorded product revenue in each of Germany, United Kingdom, Italy, France and Spain, and we expect to launch into additional smaller European markets over time.

Gross to net adjustments totaled 22.6% in Q1 2020 compared to 17.4% in Q4 2019. The sequential increase in gross to net adjustments reflects primarily an increase in the U.S. contracting and government-related programs and the impact of growing European sales that generally have higher GTN rates. We expect gross to net adjustments to remain in this low 20% range, depending on revenue and distribution mix for the U.S. and Europe. The number of weeks in distributor inventory was flat at the end of Q1 versus Q4, so there was no buildup of inventory as a result -- as a reaction to COVID-19.

At this point in time, we have no issues with either drug supply or distribution of drug to the patient. We have described product supply costs as a meaningful part of our cash spend over the last couple of years as we transition to a new manufacturing facility, so we are in a favorable position for some time to come.

Turning now to a discussion of cash. As of March 31, we had $228.4 million in cash, cash equivalents and available for sale securities. In January 2020, the company repurchased $123.4 million aggregate principal amount of its 4.5% convertible senior notes due 2024 that were initially issued in August 2019. In April 2020, the company exchanged approximately $36 million in aggregate principal amount of its 4.5% convertible senior notes due 2024 in exchange for approximately $32.8 million in aggregate principal of 2021 notes held by such holder. In May 2020, a holder of the 4.5% convertible notes due 2024, converted $24.3 million par value of notes into approximately 3.3 million shares of common stock per the standard terms of the indenture. Following these transactions, approximately $64.4 million aggregate principal amount of these 2021 notes remain outstanding and approximately $150.6 million in aggregate principal amount of these 2024 notes remain outstanding. Additionally, the company has $300 million aggregate principal amount outstanding of its 1.25% convertible notes due 2025.

As a result of the transactions noted above, the company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019, through May 5, 2020. And as of March 31, we had drawn approximately $50 million under the TPG ATHENA clinical trial financing and had up to $125 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the company's anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available for sale securities, we believe we have sufficient cash, cash equivalents and available for sale securities to fund our operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off unless we refinance earlier the remaining $64.4 million aggregate principal amount of the 2.5% convertible notes at their maturity in September 2021. While we did not see an impact in Q1 on our revenues, the effects of COVID-19 on our future sales are difficult to assess or predict, and we may see some near-term impact on revenues related to COVID-19. Net cash used in operating activities was $82.5 million for Q1 2020 compared to $98.5 million for Q1 2019. In addition, borrowings under the TPG ATHENA financing provided $15.6 million in cash in Q1 2020, reducing net cash utilized in operating activities to $66.9 million during the quarter. Net cash used in operating activities for Q1 2020 included product supply costs of $12.4 million and once-a-year annual incentive compensation payment. We expect product supply costs will be significantly reduced from this first quarter level for the remainder of 2020 and at least the first half of 2021. We also expect significantly lower cash burn in the second half of 2020, assuming achievement of our planned revenues over that time frame.

We reported a net loss for Q1 2020 of $99.3 million or $1.39 per share compared to a net loss for the first quarter of 2019 of $86.4 million or $1.63 per share. Net loss for Q1 2020 included share-based compensation expense of $13 million compared to $13.6 million for Q1 2019. Research and development expenses totaled $68.2 million for Q1 2020 compared to $62 million for the first quarter of 2019. The increase is primarily due to higher research and development costs for Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $42.6 million for Q1 2020 compared to $47.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the first quarter of 2020, primarily due to decreased commercialization expenses for Rubraca in the U.S. and Europe. We expect savings in selling, general and administrative expenses as a result of the COVID-19 situation globally.

Lastly, we continue to explore ways to improve our balance sheet and capital structure and extend our cash balance beyond the second half of 2021. As noted, we expect our R&D expenses to decrease in 2021 compared to 2020. SG&A expenses should be lower in the upcoming months, and we expect they will be in line with the Q1 2020 levels through 2021. Our inventory purchases and other nonrecurring milestone payment expenses will significantly decrease through 2021, and we anticipate planned revenues to increase with growth in all geographies and with our anticipated prostate indication approval and launch in the U.S. All of these factors should contribute to a reduction in quarterly cash burn into and through 2021. Back to you, Pat.

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [5]

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Thanks, Dan. In summary, we're pleased with our progress in the first quarter, and we believe that Rubraca is well positioned as a maintenance therapy of choice for recurrent ovarian cancer patients in the acute and in the coming chronic COVID-19 environment. Physicians will continue to seek to reduce patient visits to their clinics, and Rubraca offers certain advantages to achieve this goal. Rubraca is an oral agent delivered to and taken at home. Rubraca has been shown to extend progression-free survival by independent assessment by nearly 14 months on average compared to placebo or observation, which has shown PFS of only 5 months on average. And Rubraca requires only monthly routine monitoring, thus limiting patient visits to the clinic. We believe these equalities offer a compelling argument for clinicians to consider Rubraca in the maintenance setting for recurrent ovarian cancer. And soon, we hope to offer a new therapeutic option for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer patients in the U.S. as well.

We remain focused on managing our net cash utilized operations and improving our balance sheet through convertible debt and other transactions such as the transactions which occurred in January, April and May of this year. And last, but certainly not least, I'd like to acknowledge our employees, all of whom have been working from home since mid-March, and I am grateful for their ongoing commitment to support patients, health care providers and each other during this challenging and unprecedented time.

And with that, we're happy to answer any questions you may have.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from Kennen MacKay with RBC Capital Markets.

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Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [2]

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Congrats on the operational progress despite the pandemic. Pat, it seems like maybe you really have had some tailwinds from the COVID pandemic going on, obviously, arising from some of the decreased toxicity on the myeloid department. Can you maybe talk about how this could read through to prostate cancer, given some of the alternative agents and the chemotherapies that are out there have maybe even more toxicity than the PARP class.

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

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Yes. As you're aware, both ASCO and FDA have encouraged physicians to consider oral therapeutics as they consider treatment options for patients. And obviously, we hope and believe that, that will continue to accrue to our advantages. I discussed not only in the ovarian cancer setting versus certain alternative infusion based products, but versus immunosuppressive chemotherapy in prostate cancer.

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Operator [4]

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Your next question comes from Gena Wang with Barclays.

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Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [5]

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Maybe first one is, any geographic differences in terms of a COVID-19 impact regarding launch? And also, second question is regarding the prostate cancer. Should we actually expect any revenue in second quarter?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [6]

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Yes. So first, as the geographic differences regarding the launch, yes. We -- it's pretty evident that, for instance, the New York metropolitan area has been hit pretty hard. And I think we probably did see an impact on sales, at least new patient starts in New York, maybe even during the quarter. As to the prostate cancer launch, there will likely be some hotspots, where distractions to the health care system occur and could temporarily impact on prescribing. I will say that with a PDUFA date on May 15 and being prepared to launch on or before May 15, we absolutely would expect to see sales in prostate cancer in the second quarter. We'll have 6 weeks of sales.

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Huidong Wang, Barclays Bank PLC, Research Division - Research Analyst [7]

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Okay. That's very helpful. If I may just squeeze one more question. Any thoughts on ZEJULA approval in the first-line ovarian cancer? And then, how would that impact the competitive landscape and your ATHENA trial readout?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [8]

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So one, it was totally expected. And so it came as expected and are approved. It is not going to have any impact on our ATHENA readout. The trial is almost fully enrolled, so it will have no impact on enrollment, obviously. And in fact, we aren't even enrolling in the United States. We've started shutting down country by country, certain areas, and we've already shut down enrollment in the U.S. So it will have no impact on the timing of our readout for ATHENA.

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Operator [9]

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Your next question comes from Michael Schmidt with Guggenheim Securities.

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Yige Guo, Guggenheim Securities, LLC, Research Division - Associate [10]

Excerpt from:
Edited Transcript of CLVS earnings conference call or presentation 5-May-20 8:30pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

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Recommendation and review posted by Bethany Smith

Therapeuticsmd

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Male Hypogonadism Therapy Market 2020 | Growth Drivers, Challenges, Trends, Market Dynamics and Forecast to 2026 - Cole of Duty

Recommendation and review posted by Bethany Smith

Given the debilitating impact of COVID-19 (Coronavirus) on the Male Hypogonadism market, companies are vying opportunities to stay afloat in the market landscape. Gain access to our latest research analysis on COVID-19 associated with the Male Hypogonadism market and understand how market players are adopting new strategies to mitigate the impact of the pandemic.

Analysis of the Global Male Hypogonadism Market

Persistence Market Research (PMR) recently published a market study which provides a detailed understanding of the various factors that are likely to influence the Male Hypogonadism market in the forecast period (20XX-20XX). The study demonstrates the historical and current market trends to predict the roadmap of the Male Hypogonadism market in the coming years. Further, the growth opportunities, capacity additions, and major limitations faced by market players in the Male Hypogonadism market are discussed.

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The impact of the coronavirus on the Male Hypogonadism Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 20582019-2019 - Jewish Life News

Recommendation and review posted by Bethany Smith

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Testosterone Cypionate Market 2020: Potential growth, attractive valuation make it is a long-term investment | Know the COVID19 Impact | Top Players:...

Recommendation and review posted by Bethany Smith

Government efforts to slow the spread of the SARS-CoV-2 virus have had severe negative consequences for the economy. While that includes obvious industries such as restaurants and air travel, the trickle of first-quarter 2020 earnings reported to date have demonstrated that most economic sectors have been affected in at least some way.

Investors should likely expect that to include genetic testing services offered by Invitae (NYSE:NVTA), which reports first-quarter 2020 operating results after the market closes on May 5. The company has pursued a growth-at-all-costs business strategy that hinges on bringing clinical-grade genetic testing to the masses. To succeed, it needs to provide seamless telemedicine capabilities, which are now being tested sooner than expected by the coronavirus pandemic. Will the company get a passing grade and maintain its growth trajectory?

Image source: Getty Images.

Invitae offers genetic testing services to diagnose disease, inform treatment options, screen individuals for health risks, and guide health decisions during pregnancy. Many tests can be purchased online and processed with a saliva sample. The relative simplicity of sample collection suggests a trip to the doctor's office isn't required, even if clinician support is necessary to complete the ordering process.

That could help Invitae to avoid a decline of similar magnitude to NeoGenomics (NASDAQ:NEO). The oncology reference lab processes various types of cancer diagnostics, including genetic tests, at its 11 global laboratories for hospitals and biopharmaceutical companies. It experienced a 25% to 30% decline in test volumes in April 2020 compared to the year-ago period, but many of the samples it processes are more complex than saliva.

But investors can't be sure Invitae's business will avoid severe negative impacts from stay-at-home orders. The ability to do so rests largely on the success of the company's telemedicine capabilities, which also happens to be a key component of the push to make clinical-quality genetic testing part of routine healthcare.

Invitae launched its first telemedicine initiative in June 2019. The goal was to enable a smooth experience for consumers to order medical genetic testing online. To overcome a lack of local genetic testing providers and expert input, the company designed a process guided by expert genetic counseling services that was seamlessly integrated with its state-of-the-art labs. Tests could be ordered and tracked online, with final results sent directly to a patient's personal physician.

Those nascent telemedicine capabilities were bolstered in November 2019 with the acquisition of Clear Genetics, which developed chatbots for providing genetic services at scale. The HIPAA-compliant software product, named Gia, guides doctors and patients through the process for ordering medical genetic testing directly through Invitae.

In early April, Gia received a timely upgrade to make it easier for telehealth providers to determine testing options, order diagnostics, and ensure samples are delivered to laboratories. Results can also be easily accessed and discussed during telemedicine sessions.

Will it be enough to help Invitae avoid a coronavirus slowdown? Perhaps, but investors might want to consider that the bigger obstacle may not be convenience, but awareness. Genetic testing is still a relatively new service in most doctor's offices. The availability of Gia might not matter much if patients and doctors don't know it, or Invitae's growing menu of genetic tests, exists.

Image source: Getty Images.

Given the sudden arrival of the coronavirus pandemic and stay-at-home orders, it's probably unrealistic for investors to expect Invitae to make a seamless transition to telemedicine services. Investors should prepare for the business to be negatively affected -- at least temporarily.

That said, the investment in telemedicine and telehealth capabilities such as Gia give the company a unique advantage in a highly fragmented genetic testing space. The same holds true for the company's relatively unusual focus on providing clinical-grade genetic testing services directly to consumers, which many competitors have mostly resisted to date. Whether it helps Invitae to offset the negative consequences of the coronavirus pandemic or make up for growing losses incurred by the company's growth-at-all costs business model remain to be seen, but investors will get an answer when first-quarter 2020 earnings are released this week.

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The Coronavirus Pandemic Will Test Invitae's Telemedicine Ambitions - Motley Fool

Recommendation and review posted by Bethany Smith

Market Expertz have recently published a new report on the global At-home Genetic Testing market. The study provides profound insights into updated market events and market trends. This, in turn, helps one in better comprehending the market factors, and strongly they influence the market. Also, the sections related to regions, players, dynamics, and strategies are segmented and sub-segmented to simplify the actual conditions of the industry.

The study is updated with the impacts of the coronavirus and the future analysis of the industrys trends. This is done to ensure that the resultant predictions are most accurate and genuinely calculated. The pandemic has affected all industries, and this report evaluates its impact on the global market.

To get a sample pdf with the skeleton of the Global At-home Genetic Testing Market Report, click here: https://www.marketexpertz.com/sample-enquiry-form/53236

The report displays all leading market players profiles functioning in the globalAt-home Genetic Testingmarket with their SWOT analysis, fiscal status, present development, acquisitions, and mergers. The research report comprises of extensive study about various market segments and regions, emerging trends, major market drivers, challenges, opportunities, obstructions, and growth limiting factors in the market.

The report also emphasizes the initiatives undertaken by the companies operating in the market including product innovation, product launches, and technological development to help their organization offer more effective products in the market. It also studies notable business events, including corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions.

Leading At-home Genetic Testing manufacturers/companies operating at both regional and global levels:

23andMeMyHeritageLabCorpMyriad GeneticsAncestry.comQuest DiagnosticsGene By GeneDNA Diagnostics CenterInvitaeIntelliGeneticsAmbry GeneticsLiving DNAEasyDNA

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

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Dominant participants of the market analyzed based on:

The competitors are segmented into the size of their individual enterprise, buyers, products, raw material usage, consumer base, etc. Additionally, the raw material chain and the supply chain are described to make the user aware of the prevailing costs in the market. Lastly, their strategies and approaches are elucidated for better comprehension. In short, the market research report classifies the competitive spectrum of this globalAt-home Genetic Testingindustry in elaborate detail.

Key highlights of the report:

Market revenue splits by most promising business segments by type, by application, and any other business segment if applicable within the scope of the globalAt-home Genetic Testingmarket report. The country break-up will help you determine trends and opportunities. The prominent players are examined, and their strategies analyzed.

The Global At-home Genetic Testing Market is segmented:

In market segmentation by types of At-home Genetic Testing, the report covers-

Diagnostic ScreeningPGDRelationship testing

In market segmentation by applications of the At-home Genetic Testing, the report covers the following uses-

OnlineOffline

This At-home Genetic Testing report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

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Moreover, the report studies the competitive landscape that this industry offers to new entrants. Therefore, it gives a supreme edge to the user over the other competitors in the form of reliable speculations of the market. The key developments in the industry are shown with respect to the current scenario and the approaching advancements. The market report consists of prime information, which could be an efficient read such as investment return analysis, trends analysis, investment feasibility analysis and recommendations for growth.

The data in this report presented is thorough, reliable, and the result of extensive research, both primary and secondary. Moreover, the globalAt-home Genetic Testingmarket report presents the production, and import and export forecast by type, application, and region from 2020 to 2027.

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To summarize, the global At-home Genetic Testing market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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At-home Genetic Testing Market 2020 | In-Depth Study On The Current State Of The Industry And Key Insights Of The Business Scenario By 2027 - Cole of...

Recommendation and review posted by Bethany Smith

Hereditary cancer syndromes account for approximately 5% to 10% of all cancers, including those of the female reproductive organs.1 It is important to identify patients at risk for inherited cancer syndromes to manage and prevent various syndrome-associated malignancies.

The management of women at increased risk for hereditary gynecologic cancer specifically has to take into consideration unique concerns regarding fertility and hormonal health, with the use of appropriate fertility preservation strategies and hormone therapy, according to an evidence-based review by the Society of Gynecologic Oncology and American Society for Reproductive Medicine published jointly in Gynecologic Oncology and Fertility & Sterility.2

The most common conditions associated with gynecologic cancers include hereditary breast and ovarian cancer and hereditary nonpolyposis colorectal cancer, also known as Lynch syndrome.2 Other genetic cancer syndromes that have been linked to increased risk for gynecologic malignancy include Peutz-Jeghers syndrome and Cowden syndrome.1

Hereditary breast and ovarian cancer accounts for approximately 5% of breast cancers and 10% to 25% of ovarian cancers.2 Mutations of the genes breast cancer 1 (BRCA1) and 2 (BRCA2) account for the majority of hereditary ovarian, tubal, and peritoneal cancers.3

Several other pathogenic variants are associated with an increased risk for ovarian cancer but not breast cancer, including variants in BRIP1, RAD51C, and RAD51D. Other pathogenic variants that are associated with an increased risk for breast cancer without a significantly increased risk for ovarian cancer include variants in TP53, CDH1, CHEK2, and ATM.2

Lynch syndrome is associated with increased risk for various solid malignancies other than gynecologic cancers, especially colorectal cancer, with Lynch genes varying in penetrance.2

The International Federation of Gynecology and Obstetrics (FIGO) guidelines detail criteria for genetic risk assessment in hereditary breast and ovarian cancer, based on personal or family history of ovarian and breast cancer, age at diagnosis of the breast or ovarian cancer, or having a close relative with a known mutation or a family history indicative of Lynch syndrome.4

Once a mutation is identified, the patient should be counseled regarding risk-reducing surgery, other risk-reduction strategies, and altered screening.

Screening: Although early detection of malignancies may improve prognosis, there are no effective screening tests for ovarian cancer, even in those at high risk for the malignancy. Transvaginal ultrasound and the cancer antigen 125 (CA 125) test may have a role in these cases.2

Chemoprevention: Several classes of drugs have been investigated for chemoprevention of ovarian cancer, but only oral contraceptives were found to potentially reduce risk for the malignancy. However, several studies have reported a possible increased risk for breast cancer with oral contraceptive in the general population and in women with BRCA1 or BRCA2 mutations.2

Risk-reducing surgery: Women with BRCA1 or BRCA2 mutations should be offered risk-reducing salpingo-oophorectomy by age 35 years or when childbearing is complete, but some countries recommend surgery at age 40 years or at an age that is 5 years younger than the youngest affected family member.4 Women with Lynch syndrome should be offered prophylactic total hysterectomy and bilateral salpingo-oophorectomy after the completion of childbearing, especially after age 40 years, as these measures have been shown to decrease the risk for endometrial and ovarian cancer in this patient population.2

There are multiple fertility-preservation and family-building strategies that can be used to help women achieve their goals, including oocyte and/or embryo cryopreservation; use of donor oocytes, donor embryos, and/or gestational carriers; and adoption.2

Women with BRCA1 or BRCA2 pathogenic variants should be referred early to reproductive endocrinologists, as discussions with physicians and ovarian reserve testing may help inform patients decisions on if and when to pursue fertility preservation.2

Patients have the option to cryopreserve and store oocytes and/or embryos using assisted reproductive technology. Although embryo cryopreservation is an effective strategy for fertility preservation, the success rate is dependent on multiple factors. The use of fertility drugs is not associated with a greater risk for invasive breast, ovarian, or uterine cancer in the general population. There is also no known increased risk for breast cancer with fertility medications in BRCA mutation carriers, but there are limited data on the risk for ovarian cancer in these patients.2

Additional options for parenthood include hormonally priming the uterus for embryo transfer after risk-reducing salpingo-oophorectomy. Even women who have undergone hysterectomy but who have retained ovaries can have children using their own gametes through in vitro fertilization with a gestational carrier. Uterine transplantation is still a novel procedure and its role in fertility preservation has not yet been determined.2

Embryo biopsies for preimplantation genetic testing (PGT) should be offered to carriers of known pathogenic gene variants. Analysis for monogenic/single gene defects (PGT-M) can aid in selecting embryos for intrauterine transfer and serve as an alternative to prenatal testing. However, one study found that only approximately one-third of high-risk women would theoretically use PGT-M themselves.2

Chorionic villus sampling and amniocentesis may be used to assess fetal karyotype and certain chromosomal abnormalities, but as of 2018, it is still considered a screening test primarily for aneuploidy that should not be used for prenatal diagnosis of a cancer risk gene.5

Surgical intervention can result in menopausal symptoms at a young age, including vasomotor symptoms, cognitive changes, increased risk for cardiovascular disease, and osteoporosis. Hormonal therapy may alleviate some of these symptoms, but its use in patients at greater risk for gynecologic and breast cancers is controversial and limited data are available on the safety of hormonal therapy for women with BRCA1 or BRCA2 mutations or those with Lynch syndrome. As the benefits of hormone therapy may outweigh the risks secondary to premature estrogen loss, this option should be considered for women without a personal history of breast cancer.2

Nonhormonal options to reduce vasomotor symptoms include selective serotonin reuptake inhibitors, alpha-2 adrenergic agonists, dietary and lifestyle changes, and alternative medicine approaches.2

Providers who care for women at risk for hereditary gynecologic cancers must consider the impact of these conditions on reproductive and hormonal health, stated the authors of the Society of Gynecologic Oncology and American Society for Reproductive Medicine review. These considerations include discussions about options for cancer prevention, fertility preservation and family planning, and management of early surgical menopause in these patients.

References

1. Ballinger LL. Hereditary gynecologic cancers: risk assessment, counseling, testing and management. Obs Gynecol Clin N Am. 2012;39(2):165-181.

2. Chen L-M, Blank SV, Burton E, Glass K, Penick E, Woodard T. Reproductive and hormonal considerations in women at increased risk for hereditary gynecologic cancers: Society of Gynecologic Oncology and American Society for Reproductive Medicine evidence-based review. Fertil Steril. 2019;112(6):1034-1042.

3. Shaw PA, Clarke BA. Prophylactic gynecologic specimens from hereditary cancer carriers. Surg Pathol. 2016;9(2):307-328.

4. Mutch D, Denny L, Quinn M; for the FIGO Committee on Gynecologic Oncology. Hereditary gynecologic cancers. Int J Gynecol Obstet. 2014;124(3):189-192.

5. American College of Obstetricians and Gynecologists Committee on Practice Bulletins. Practice bulletin No. 163 summary: screening for fetal aneuploidy. Obs Gynecol. 2016;127(5):979-981.

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Management of Fertility and Hormonal Health in Women at Risk for Hereditary Gynecologic Cancers - Endocrinology Advisor

Recommendation and review posted by Bethany Smith

SAN FRANCISCO, May 5, 2020 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced financial and operating results for the first quarter ended March 31, 2020.

"We started the year with a very strong quarter, delivering record growth in volume and first quarter revenues and giving us strong momentum as we began experiencing impacts from the pandemic. As healthcare has shifted, we have been able to quickly leverage our pre-existing strengths, notably our telehealth offerings and our ability to deliver genetic testing remotely," said Sean George, co-founder and chief executive officer of Invitae. "Looking ahead, our investments in diversified products, services, technologies and geographies mean we are well-equipped to drive growth across an increasing number of customer segments as we drive genetics into mainstream medicine."

First Quarter 2020 Financial Results

Total operating expense, excluding cost of revenue, for the first quarter of 2020 was $121.6 million. Non-GAAP operating expense, which excludes amortization of acquired intangible assets and acquisition-related stock-based compensation, was $101.9 million in the first quarter of 2020. Interest and other expense, net and net loss are preliminary and subject to change as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae's Form 10-Q to be filed with the SEC on or before May 11, 2020.

Preliminary net loss for the first quarter of 2020 was $102.2 million, or $1.03 preliminary net loss per share, compared to a net loss of $37.7 million in the first quarter of 2019, or $0.47 net loss per share. Preliminary non-GAAP net loss was $79.8 million in the first quarter of 2020, or $0.80 preliminary non-GAAP net loss per share.

At March 31, 2020 cash, cash equivalents, restricted cash, and marketable securities totaled $301.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $61.0 million. Cash burn, including various acquisition-related expenses, was $98.5 million for the quarter; $66.2 million when excluding $32.3 million cash paid to acquire Diploid.

In April, the company completed a public offering of common stock, resulting in gross proceeds of $184.0 million and $173.0 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.

COVID-19 ImpactGlobal stay-at-home orders, lockdowns and shutdown of non-emergency healthcare and elective procedures began impacting Invitae during the second half of March. Invitae took a number of steps in response, including:

The impact of the pandemic on testing volume has and is likely to continue to vary based on clinical area, geography and clinician type. In response, the company has taken a number of steps to reduce cash burn.

The company is continuing to closely monitor the impact of the COVID-19 pandemic and plans to continue to reduce previously communicated cash burn through the remainder of 2020.

Given the unknown duration and extent of COVID-19's impact on our business, and the healthcare system in general, Invitae has previously withdrawn its 2020 guidance.

Corporate and Scientific Highlights

Webcast and Conference Call DetailsManagement will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 9557177. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

The live webcast of the call and slide deck may be accessed by visiting the investors section of the company's website atir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company's website.

About InvitaeInvitae Corporation(NYSE: NVTA)is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to preliminary financial results, including preliminary net loss and net loss per share; the company's belief that it has been able to quickly leverage its telehealth offerings and its ability to deliver genetic testing remotely; he company's belief that it is well-equipped to drive growth across an increasing number of customer segments as it drives genetics into mainstream medicine; the impact of the COVID-19 pandemic on the company's business, and the measures it has taken or may take In the future with respect thereto; the impact of the company's acquisitions, partnerships and product offerings; and the company's beliefs regarding the growth of its business, its position and impact on the genetic testing industry, its success in executing on its mission and achieving its goals, and the benefits of genetic testing. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic on the company, and the effectiveness of the efforts it has taken or may take in the future in response thereto; the completion of the closing process, including finalization of acquisition-related adjustments and the magnitude thereof; the company's ability to continue to grow its business, including internationally; the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company's failure to successfully integrate or fully realize the anticipated benefits of acquired businesses; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Non-GAAP Financial MeasuresTo supplement Invitae's consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States (GAAP), the company is providing several non-GAAP measures, including non-GAAP gross profit, non-GAAP cost of revenue, non-GAAP operating expense, including non-GAAP research and development, non-GAAP selling and marketing and non-GAAP general and administrative, as well as non-GAAP net loss and net loss per share and non-GAAP cash burn. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly-titled measures presented by other companies. Management believes these non-GAAP financial measures are useful to investors in evaluating the company's ongoing operating results and trends.

Management is excluding from some or all of its non-GAAP operating results (1) amortization of acquired intangible assets and (2) acquisition-related stock-based compensation related to inducement grants. These non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact on the reported financial results. Management accounts for this limitation by analyzing results on a GAAP basis as well as a non-GAAP basis and also by providing GAAP measures in the company's public disclosures.

Cash burn excludes (1) changes in marketable securities and (2) cash received from exercises of warrants. Management believes cash burn is a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business. A limitation of using this non-GAAP measure is that cash burn does not represent the total change in cash, cash equivalents, and restricted cash for the period because it excludes cash provided by or used for other operating, investing or financing activities. Management accounts for this limitation by providing information about the company's operating, investing and financing activities in the statements of cash flows in the consolidated financial statements in the company's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and by presenting net cash provided by (used in) operating, investing and financing activities as well as the net increase or decrease in cash, cash equivalents and restricted cash in its reconciliation of cash burn.

In addition, other companies, including companies in the same industry, may not use the same non-GAAP measures or may calculate these metrics in a different manner than management or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of these non-GAAP measures as comparative measures. Because of these limitations, the company's non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. Investors are encouraged to review the non-GAAP reconciliations provided in the tables below.

INVITAE CORPORATION

Consolidated Balance Sheets

(in thousands)

(unaudited)

March 31,2020

December 31,2019

Assets

Current assets:

Cash and cash equivalents

$

90,220

$

151,389

Marketable securities

204,388

240,436

Accounts receivable

37,734

32,541

Prepaid expenses and other current assets

25,085

18,032

Total current assets

357,427

442,398

Property and equipment, net

41,085

37,747

Operating lease assets

37,588

36,640

Restricted cash

6,343

6,183

Intangible assets, net

163,378

125,175

Goodwill

177,432

126,777

Other assets

7,635

6,681

Total assets

$

790,888

$

781,601

Liabilities and stockholders' equity

Total liabilities and stockholders' equity

$

790,888

$

781,601

Certain line items have been condensed as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae's Form 10-Q to be filed with the SEC on or before May 11, 2020.

INVITAE CORPORATION

Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

Three Months EndedMarch 31,

2020

2019

Revenue:

Test revenue

$

63,078

$

39,619

Other revenue

1,170

934

Total revenue

64,248

40,553

Cost of revenue

40,422

21,254

Research and development

55,668

17,994

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Invitae Reports More Than $64 Million in Revenue Driven by More Than 154,000 Samples Accessioned in the First Quarter of 2020 - PRNewswire

Recommendation and review posted by Bethany Smith

On Maharashtra Day on May 1, the Indian Institute of Technology (IIT) Alumni Council launched a test bus that can reduce the cost of testing by over 80% without compromising on the testing capacity. IIT Alumni Council is a global alumni body for all the twenty three IITs.

The IIT Alumni Council has taken a proactive approach to supporting the Governments efforts in fighting the Covid-19 challenge. We have acted swiftly and set up the IIT C19 Task Force to channelise the energies of the global IIT Alumni for this fight, said Ravi Sharma, President, IIT Alumni Council.

The move is aimed at supporting the health department in tackling the pandemic that has caused 361 deaths and over 11,000 infections in Mumbai alone. Indias testing capacity stood at 177 tests per million, as on April 15.

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The IIT C19 Test Bus is based on the Kodoy architecture model that can facilitate affordable and rapid testing. It involves e-vehicles for sample selection & telemedicine, algorithm based pooled genetic testing and megalabs that are capable of conducting up to five million tests per month per lab.

The Covid-19 Test Bus is based on indigenous technology and to the best of our knowledge, is the first vehicle of its kind in the world with onboard genetic testing, AI-based teleradiology and contactless sample collection. We chose Mumbai as the launch location given the relatively high number of cases in the city, Sharma said.

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At first, a digital chest x-ray would be carried out and sent to the doctors online. The healthcare staff will then use artificial intelligence to see the probability of a person having Coronavirus.

Then we collect the swab from the mouth and throat which is done across a glass screen whilst fully protecting the technician from any kind of contact with the patient, said Dr Muffazal Lakadawala, Chief Medical Officer at the NSCI hub.

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To onboard the lab space on the test bus, the IIT Alumni Council has partnered with Krsnaa Diagnostics, a venture-capital funded laboratory in India.

See also:Googles mobility report reveals that nearly half of Maharashtras workforce went to work despite Coronavirus lockdownAdvertisement

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IIT launches a Covid-19 Test Bus in Mumbai capable of conducting 5 million tests per month - Business Insider India

Recommendation and review posted by Bethany Smith

The great American Zen poet and eco-warrior Gary Snyder turns 90 on Friday. Ive been thinking a lot about Snyder lately, along with other nature-minded writers like Annie Dillard and Barry Lopez, as Ive grown more restless during lockdown and started spending time in the deep woods where I live. (OK, theyre not that deep. But neither was Walden Thoreau brought laundry to his mothers house! and they at least give the illusion of solitude.) Snyders no hermit. One thing I admire about his work is its sense of fellowship: how alert it is to the links between land and politics and culture. He writes about nature, sure, but also about human nature. In honor of his birthday, maybe spend a few minutes reading Axe Handles or Above Pate Valley.

Theres not much nature on this weeks list of recommended titles, but theres plenty of politics and culture. You could read Lawrence Wrights prescient new pandemic thriller, The End of October, if you dare. You say you prefer your world affairs without viruses? In that case we might suggest Dalia Sofers novel Man of My Time, about an Iranian mans path from revolutionary to government interrogator, or Gotz Alys history Europe Against the Jews, about the 19th-century political spasms that led to the Holocaust. Theres In Deep, in which David Rohde investigates the alleged existence of a bureaucratic deep state, or The Inevitability of Tragedy, in which Barry Gewen (a longtime editor at the Book Review) traces the roots of Henry Kissingers political philosophy. Or theres Nobodys Child, Susan Nordin Vinocours incisive look at the problems and promise of the insanity defense as its used in American jurisprudence.

We also recommend a Gothic novel set in the Italian Alps, a story collection about refugees and immigrants in North America, a memoiristic biography of the woman who founded Weight Watchers, and an immersion in the ways of French cooking courtesy of Bill Bufords Dirt which, come to think of it, has a lot to do with nature after all.

Gregory CowlesSenior Editor, BooksTwitter: @GregoryCowles

THE END OF OCTOBER, by Lawrence Wright. (Knopf, $27.95.) The sweeping, authoritative and genuinely intelligent thriller the sort of novel in which the author employs a bulldozer and a scalpel at the same time is a rare specimen, our critic Dwight Garner writes, and The End of October is one of those rarities. The fact that its about the world in shock and ruin because of a virus similar to Covid-19 makes it read as if its been shot out of a cannon.

MAN OF MY TIME, by Dalia Sofer. (Farrar, Straus & Giroux, $27.) Sofers second novel traces a mans path from baffled revolutionary in Iran to complicit actor in a ruthless regime sure he can undermine the system from inside. It is a master class in layering together a character who is essentially unforgivable but no less captivating. With Sofers considerable talents, the betrayals (of both self and others) that leave Hamid a brittle shell of a man are fully worthy of our intense gaze, Rebecca Makkai writes in her review.

THE ANCESTOR, by Danielle Trussoni. (Morrow/HarperCollins, $27.99.) When a genetic testing site reveals ordinary Bert Monte to be Countess Alberta Montebianco, heiress to a grand old estate in the Italian Alps, she decides to claim her birthright. Trussonis Gothic novel explores what happens next. The central contradictions in The Ancestor reside in the questions of who we are and where we belong of what divides us and what unites us, Carol Goodman writes in her review. Those are the mysteries were invited to discover in this chilling and inventive novel.

NOBODYS CHILD: A Tragedy, a Trial and a History of the Insanity Defense, by Susan Nordin Vinocour. (Norton, $28.95.) The insanity defense, deployed in fewer than 1 percent of criminal cases and successful only about a quarter of the time, nevertheless looms large in debates about crime and punishment. Vinocour shows the injustices of this sliver of our legal system meant to bring together psychiatric research and criminal law. She makes her case delicately, every page offering an incriminating new piece of evidence, scientific fact or court case that demonstrates just how unjust our legal system is to anyone suffering the misfortune of mental illness, our reviewer, Rachel Louise Snyder, writes.

THE INEVITABILITY OF TRAGEDY: Henry Kissinger and His World, by Barry Gewen. (Norton, $30.) In this magisterial account, Gewen, a longtime editor at the Book Review, traces the historical and philosophical roots of Kissingers famous realism, situating him in the context of Hannah Arendt and a cohort of other Jewish intellectuals who escaped Nazi Germany. The book is a timely and acute defense of the great realists actions, values and beliefs, according to John A. Farrells review. Gewens book is a thoughtful rumination on human behavior, philosophy and international relations,

IN DEEP: The FBI, the CIA, and the Truth About Americas Deep State, by David Rohde. (Norton, $30.) Rohde examines Donald Trumps contention that there is a deep state trying to undermine his presidency, offering a history of the conspiracy theory and concluding that, despite the presence of an institutional government made up of career civil servants, there is no such thing. Some of the books most fascinating passages trace the rise of William Barr, Trumps attorney general, from his time as a C.I.A. intern, Fred Kaplan writes in his review. Rohde highlights Barrs activism, along with a small group of other conservative lawyers, in the Federalist Society and the Catholic Information Center, which now exercise enormous influence. The tale of these groups is worth an entire book.

HOW TO PRONOUNCE KNIFE: Stories, by Souvankham Thammavongsa. (Little, Brown, $26.) Most of the characters in this spare and rigorous debut collection by Thammavongsa, a Canadian writer and poet, are immigrants in unnamed North American cities, struggling with loneliness and the challenges of mastering the English language. Thammavongsas spare, rigorous stories are preoccupied with themes of alienation and dislocation, her characters burdened by the sense of existing unseen, Sarah Resnick writes in her review. Thammavongsas gift for the gently absurd means the stories never feel dour or predictable, even when their outcomes are by some measure bleak.

THIS IS BIG: How the Founder of Weight Watchers Changed the World and Me, by Marisa Meltzer. (Little, Brown, $28.) This is a story of kinship between two women who never met: Meltzer, a journalist, and Jean Nidetch, the founder of Weight Watchers. The two have more in common than their struggles with the scale, as Meltzer frankly details. By toggling between Nidetchs story and her own, Meltzer positions herself and the weight-loss icon as battle buddies of a sort, separated by time and space, yet bound by efforts to lose weight and to thrive within the boundaries imposed on women of their respective generations, our reviewer, Lily Burana, writes. Meltzer has created a singular companionate text for those who know the agony of frustration surrounding weight as an issue, both personal and political.

EUROPE AGAINST THE JEWS: 1880-1945, by Gotz Aly. (Metropolitan/Holt, $32.99.) The origins of the Holocaust, Aly argues, are to be found in the rise of nationalism and the persecution of minorities that began in the late 19th century and solidified in the welter of new nation-states after World War I. Alys reminder of the usefulness of taking a close look at the quiet horrors of Europes interwar years feels all the more valuable today, Steven J. Zipperstein writes in his review. And his acknowledgment that comparisons between now and then once the province of the ill-informed deserve more serious attention from historians and others is just one of many reminders as to how far weve stumbled into an age of troubled sleep.

DIRT: Adventures in Lyon as a Chef in Training, Father, and Sleuth Looking for the Secret of French Cooking, by Bill Buford. (Knopf, $28.95.) Buford, whose last book was about Italian food, here delivers a delightful exploration of his immersion in French cuisine and its soul. This book may well be an even greater pleasure than its predecessor, Lisa Abend writes, reviewing it alongside two other culinary memoirs. He tangles with the btes noires of every Anglophone in France the language, the bureaucracy, the arrogance and embarks, to the great nationalistic dismay of all around him, on a quixotic investigation to prove an Italian origin theory for pot au feu and other French classics.

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10 New Books We Recommend This Week - The New York Times

Recommendation and review posted by Bethany Smith

Market OverviewThe global Cryogenics Equipment market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.

The Cryogenics Equipment market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

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Market segmentationCryogenics Equipment market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

By Type, Cryogenics Equipment market has been segmented intoCryogenic TanksCryogenic ValveCryogenic VaporizerCryogenic PumpOther

By Application, Cryogenics Equipment has been segmented into:Energy & PowerChemicalsMetallurgyElectronicsShippingOther

Regions and Countries Level AnalysisRegional analysis is another highly comprehensive part of the research and analysis study of the global Cryogenics Equipment market presented in the report. This section sheds light on the sales growth of different regional and country-level Cryogenics Equipment markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Cryogenics Equipment market.

The report offers in-depth assessment of the growth and other aspects of the Cryogenics Equipment market in important countries (regions), including:North America (United States, Canada and Mexico)Europe (Germany, France, UK, Russia and Italy)Asia-Pacific (China, Japan, Korea, India and Southeast Asia)South America (Brazil, Argentina, etc.)Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

Access Complete Global Cryogenics Equipment Market Report @ https://arcognizance.com/report/global-cryogenics-equipment-market-2020-by-manufacturers-regions-type-and-application-forecast-to-2025

Competitive Landscape and Cryogenics Equipment Market Share AnalysisCryogenics Equipment competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Cryogenics Equipment sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Cryogenics Equipment sales, revenue and market share for each player covered in this report.

The major players covered in Cryogenics Equipment are:CryofabEleet cryogenicsBeijing TianhaiCryoquipJSC Cryogenmash

Among other players domestic and global, Cryogenics Equipment market share data is available for global, North America, Europe, Asia-Pacific, Middle East and Africa and South America separately. Global Info Research analysts understand competitive strengths and provide competitive analysis for each competitor separately.

The content of the study subjects, includes a total of 15 chapters:Chapter 1, to describe Cryogenics Equipment product scope, market overview, market opportunities, market driving force and market risks.Chapter 2, to profile the top manufacturers of Cryogenics Equipment, with price, sales, revenue and global market share of Cryogenics Equipment in 2018 and 2019.Chapter 3, the Cryogenics Equipment competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.Chapter 4, the Cryogenics Equipment breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2015 to 2020.Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2015 to 2020.Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2015 to 2020.Chapter 12, Cryogenics Equipment market forecast, by regions, type and application, with sales and revenue, from 2020 to 2025.Chapter 13, 14 and 15, to describe Cryogenics Equipment sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Major Point of TOC:

Chapter One: Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Sales, Revenue and Market Share by Manufacturer

Chapter Four: Global Market Analysis by Regions

Chapter Five: North America by Country

Chapter Six: Europe by Country

Chapter Seven: Asia-Pacific by Regions

Chapter Eight: South America by Country

Chapter Nine: Middle East & Africa by Countries

Chapter Ten: Market Segment by Type

Chapter Eleven: Global Cryogenics Equipment Market Segment by Application 11.1 Global Cryogenics Equipment Sales Market Share by Application (2015-2020)11.2 Global Cryogenics Equipment Revenue Market Share by Application (2015-2020)11.3 Global Cryogenics Equipment Price by Application (2015-2020)

Chapter Twelve: Market Forecast 12.1 Global Cryogenics Equipment Sales, Revenue and Growth Rate (2021-2025)12.2 Cryogenics Equipment Market Forecast by Regions (2021-2025)12.2.1 North America Cryogenics Equipment Market Forecast (2021-2025)12.2.2 Europe Cryogenics Equipment Market Forecast (2021-2025)12.2.3 Asia-Pacific Cryogenics Equipment Market Forecast (2021-2025)12.2.4 South America Cryogenics Equipment Market Forecast (2021-2025)12.2.5 Middle East & Africa Cryogenics Equipment Market Forecast (2021-2025)12.3 Cryogenics Equipment Market Forecast by Type (2021-2025)12.3.1 Global Cryogenics Equipment Sales Forecast by Type (2021-2025)12.3.2 Global Cryogenics Equipment Market Share Forecast by Type (2021-2025)12.4 Cryogenics Equipment Market Forecast by Application (2021-2025)12.4.1 Global Cryogenics Equipment Sales Forecast by Application (2021-2025)12.4.2 Global Cryogenics Equipment Market Share Forecast by Application (2021-2025)

Chapter Thirteen: Sales Channel, Distributors, Traders and Dealers 13.1 Sales Channel13.1.1 Direct Marketing13.1.2 Indirect Marketing13.2 Distributors, Traders and Dealers

Chapter Fourteen: Research Findings and Conclusion

Chapter Fifteen: Appendix 15.1 Methodology15.2 Data Source15.3 Disclaimer15.4 About US

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Note:

Due to the ongoing COVID-19 pandemic around the world, the figures in the report study represented in the study might differ along with production capacities and other mentioned aspects. Also, note that there is a possibility of a cooldown period after the pandemic that the data might differ as the world economy aims to catch on.

If you have any special requirements, please let us know and we will offer you the report as you want.

About Us:Analytical Research Cognizance (ARC)is a trusted hub for research reports that critically renders accurate and statistical data for your business growth. Our extensive database of examined market reports places us amongst the best industry report firms. Our professionally equipped team further strengthens ARCs potential. ARC works with the mission of creating a platform where marketers can have access to informative, latest and well researched reports. To achieve this aim our experts tactically scrutinize every report that comes under their eye.

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Cryogenics Equipment Market Size, Share, Analysis, Emerging-Technologies, Growth-Trends, 2020 Projections, Statistics, Applications, Software,...

Recommendation and review posted by Bethany Smith

New Study on the Global Carob Bean Gum Market by PMR

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Carob Bean Gum market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Carob Bean Gum market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Carob Bean Gum market to assist our clients arrive at beneficial business decisions.

As per the report, the global Carob Bean Gum market is expected to grow at a CAGR of ~XX% during the stipulated timeframe owing to a range of factors including, favorable government policies, and growing awareness related to the Carob Bean Gum , surge in research and development and more.

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Resourceful insights enclosed in the report:

Competitive Outlook

The competitive outlook section provides valuable information related to the different companies operating in the current Carob Bean Gum market landscape. The market share, product portfolio, pricing strategy, sales and distribution channels of each company is discussed in the report.

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Prominent players covered in the report are:

Regional Assessment

The presented market study touches upon the market scenario in different regions and provides a deep understanding of the influence of micro and macro-economic factors on the prospects of the market in each region.

key players and products offered

For any queries get in touch with Industry Expert @ https://www.persistencemarketresearch.co/ask-an-expert/26299

The market report addresses the following queries related to the Carob Bean Gum market:

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COVID-19: Responding to the business impacts of Carob Bean Gum Market Key Developments with Forecast until 2018 2026 - Jewish Life News

Recommendation and review posted by Bethany Smith

Cryogenic Tank Marketresearch Report is an inestimable supply of perceptive information for business strategists. This Cryogenic Tank Market study provides comprehensive data which enlarge the understanding, scope and application of this report.

A specific study of competitive landscape of the global Cryogenic Tank Market has alloted, providing insights into the corporate profiles, financial standing, recent developments, mergers and acquisitions, and therefore the SWOT analysis. This analysis report will provides a transparent program to readers concern regarding the general market situation to further choose on this market projects.

The Cryogenic Tank Market report profiles the successive companies, which includes: Chart Industries, Cryofab, INOX, Linde, VRV, Wessington Cryogenics

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This report studies the global Cryogenic Tank Market status and forecast, categorizes the global Cryogenic Tank Market size (value & volume), revenue (Million USD), product price by manufacturers, type, application, and region. Cryogenic Tank Market Report by Material, Application and Geography with Global Forecast to 2024 is an connoisseur and far-reaching research provide details associated with worlds major provincial economic situations, Concentrating on the principle districts (North America, South America Europe, and Asia-Pacific) and the crucial nations (United States, Germany, United Kingdom, Japan, South Korea, and China).

For product type segment, this report listed main product type of Cryogenic Tank market* Stationary Cryogenic Tanks* Trailer-Type Cryogenic TanksFor end use/application segment, this report focuses on the status and outlook for key applications.* Petrochemical Plants* Chemical Plants* Others

Market Segment by Regions, regional analysis coversNorth AmericaEuropeAsia-PacificSouth AmericaMiddle East and Africa

Table of Contents

Global Cryogenic Tank Market Size, Status and Forecast 20241 Market Overview2 Manufacturers Profiles3 Global Cryogenic Tank Sales, Revenue, Market Share andCompetitionby Manufacturer4 Global Cryogenic Tank Market Analysis by Various Regions5 North America Cryogenic Tank by Countries6 Europe Cryogenic Tank by Countries7 Asia-Pacific Cryogenic Tank by Countries8 South America Cryogenic Tank by Countries9 Middle East and Africas Cryogenic Tank by Countries10 Global Cryogenic Tank Market Segment by Types11 Global Cryogenic Tank Market Segment by Applications12 Cryogenic Tank Market Forecast13 Sales Channel, Distributors, Traders and Dealers14 Research Findings and Conclusion15 Appendix

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Overview of the chapters analysing the global Cryogenic Tank Market in detail:

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Cryogenic Tank Market set to record exponential growth by 2024 with Key Companies like Chart Industries, Cryofab, INOX, Linde, VRV, Wessington...

Recommendation and review posted by Bethany Smith

1. First CRISPR test for the coronavirus approved in the United States  Nature.com
2. FDA approves first coronavirus diagnostic test that uses CRISPR technology  ModernHealthcare.com
3. A CRISPR Way  GenomeWeb
4. FDA Approves CRISPR-Based Coronavirus Test  ExtremeTech
5. First gene-editing CRISPR test for coronavirus approved by the FDA, here is how it works  Times Now
6. View Full Coverage on Google News

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First CRISPR test for the coronavirus approved in the United States - Nature.com

Recommendation and review posted by Bethany Smith

The agency's guidelines would help companies who are making kits that allow Americans to swab themselves and send the sample into a lab all from the safety of their own home. Meanwhile, CRISPR technology could help cut testing time down to an hour. Meanwhile, as states grapple with testing questions, the porn industry could offer a template for moving forward.

The New York Times:F.D.A. Paves Way For Home Testing Of CoronavirusIn a move that could significantly expand the nations testing capacity, the Food and Drug Administration has posted new guidelines that could pave the way for millions of people to test themselves for the coronavirus at home. The guidelines allow companies to develop and market testing kits with the tools to swab their noses and mail the specimens to any lab in the country. (Jacobs, 5/7)

The Washington Post:FDA Gives Emergency Authorization For CRISPR-Based Diagnostic Tool For CoronavirusThe Food and Drug Administration on Thursday approved a new diagnostic tool that employs the revolutionary CRISPR gene-editing technology to determine in just one hour if someone is infected with the novel coronavirus. The FDAs emergency use authorization allows only high-complexity laboratories to use the test kit, developed by researchers at the Massachusetts Institute of Technology, Harvard University, the Ragon Institute and the Howard Hughes Medical Institute and marketed by Sherlock Biosciences of Cambridge, Mass. (Achenbach and McGinley, 5/7)

Boston Globe:Cambridge Biotechs Virus Test Using CRISPR Gene Editing OKd For CrisisA Cambridge biotech startup received emergency clearance Thursday for a faster and radically different laboratory test to diagnose COVID-19, a kit the company says can give results within an hour. The Food and Drug Administration provided an emergency use authorization for the test made by Sherlock Biosciences. It relies on the revolutionary genome-editing tool CRISPR, which edits DNA and has the potential to treat a vast array of diseases but had yet to win FDA approval for any product. The tool was repurposed to create a diagnostic test. (Saltzman, 5/7)

Stat:Could The Porn Industry Offer A Model For Reopening Amid Covid-19?As states and employers furiously develop plans to safely reopen workplaces in the midst of the coronavirus pandemic, theyre grappling with what seems like an endless list of questions: where to test, who to test, and how often to test for the virus? Further complicating matters are issues of workers privacy, geography, politics, science, and cost. Its a difficult mandate. But there is one place to look for guidance the adult film industry. (McFarling, 5/8)

CNN:Coronavirus: Rollout Of Antibody Tests Met With Confusion, Little OversightPublic health experts, including members of the White House Coronavirus Task Force, have argued accurate Covid-19 antibody tests can support efforts to get Americans back to work by determining who may have overcome the virus. But the rollout of millions of antibody tests in the US has created frustration and division among state health departments due to a mix of questionable tests, shifting federal rules and a hodgepodge of different methods for tracking results. (Devine, Bronstein and Griffin, 5/7)

Kaiser Health News:Trying Out LAs New Coronavirus Testing RegimeLast week, after Mayor Eric Garcetti announced that Los Angeles was offering COVID-19 tests to all city and county residents, I decided to get one myself and test Garcettis bold new promise in the bargain. I was surprised how easily I was able to log on to L.A.s testing website. I answered a few questions about myself, including whether I had any symptoms of the disease the answer was no and within three minutes, I had a same-day appointment at one of eight city-run testing sites. (Wolfson, 5/8)

San Francisco Chronicle:California Clinics, Counties Get $97 Million From Feds To Expand TestingThe U.S. Department of Health and Human Services has awarded $97.3 million to 179 California health centers to expand coronavirus testing in low-income communities, the federal agency said Thursday. The grants are part of $583 million the federal government is distributing to 1,385 health centers that receive funding from the Health Resources and Services Administration, a unit of HHS that seeks to improve health care access for uninsured and vulnerable Americans. The money comes from the federal Paycheck Protection Program and Health Care Enhancement Act, which provides funding for small businesses hurt by the pandemic and economic support for health care providers and testing efforts. (Ho, 5/7)

Atlanta Journal-Constitution:Governor Urges All Georgians To Get Testing For CoronavirusGov. Brian Kemp urged all Georgians to schedule an appointment for coronavirus screening regardless of whether they have symptoms, as the state continues to expand testing for the disease even as the rapid growth has exposed new strains. With the state no longer facing crippling shortages of key supplies, Kemp said Thursday that the capacity for testing now outstrips the publics demand in the weeks after he began to reopen parts of the economy. That has stressed area labs, however, struggling to keep up with record numbers of tests. (Bluestein and Hallerman, 5/7)

Atlanta Journal-Constitution:Ga. Heath Centers To Receive More Than $12.2 Million For COVID TestingNearly three dozen health centers in Georgia will share more than $12.2 million in federal dollars to expand testing forCOVID-19. This infusion of funding is part of nearly $583 million awarded across the U.S. and its territories by the U.S. Department of Health and Human Services to boost testing capacity. The money is going to centers funded by its Health Resources and Services Administration, which provide health care services to populations that have limited access to health care services. (Mariano, 5/7)

Boston Globe:Maine To Triple Testing Capacity For CoronavirusMaine Governor Janet Mills announced a partnership with IDEXX Laboratories, a local manufacturer, which will allow the state to more than triple its testing capacity in the coming weeks and remove testing criteria for those who believe they may have the virus. The public-private partnership will introduce a new diagnostic testing system to the states health department and bolster the states testing 2,000 tests per week to 7,000 tests per week for the foreseeable future, Mills said at a press conference Thursday afternoon. IDEXX is also lending 3,500 test kits to the states health department. (Berg, 5/7)

More here:
FDA Cutting Red Tape To Speed Development Of In-Home Tests; CRISPR Technology Gets Green Light From Agency - Kaiser Health News

Recommendation and review posted by Bethany Smith

Crispr And Crispr Associated Genes Market has recently been added to its extensive repository by Market Research Intellect. This intelligence report includes research based on current scenarios, historical records and future forecasts. In this research report, specific data on various aspects such as type, size, application and end user were checked. It offers a 360-degree overview of the competitive landscape of industries. The SWOT analysis was used to understand the strengths, weaknesses, opportunities and threats faced by companies. This helps companies understand the threats and challenges ahead. The Crispr And Crispr Associated Genes market is growing steadily and the CAGR is expected to improve over the forecast period.

The report includes the latest coverage of the impact of COVID-19 on the Crispr And Crispr Associated Genes industry. The incidence has affected nearly every aspect of the business domain. This study evaluates the current scenario and predicts future outcomes of the pandemic on the global economy.

**Our FREE SAMPLE COPY of the report gives a brief introduction of the Crispr And Crispr Associated Genes market, Detailed TOC, key players of the market, list of tables and figures and comprising key countries regions.**

We provide a detailed analysis of key players operating in the Crispr And Crispr Associated Genes Market:

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Crispr And Crispr Associated Genes market. A competition analysis is imperative in the Crispr And Crispr Associated Genes market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Crispr And Crispr Associated Genes across the world has been calculated through primary and secondary research. The Crispr And Crispr Associated Genes Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Highlights of the Crispr And Crispr Associated Genes market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Crispr And Crispr Associated Genes market. Additionally, it includes a share of every segment of the Crispr And Crispr Associated Genes market, giving methodical information about types and applications of the market.

Key point summary of the Crispr And Crispr Associated Genes market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Crispr And Crispr Associated Genes market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Crispr And Crispr Associated Genes market

Chapter 2: Evaluating the leading manufacturers of the global Crispr And Crispr Associated Genes market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Crispr And Crispr Associated Genes market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Crispr And Crispr Associated Genes market describes Crispr And Crispr Associated Genes industry expansion game plan, the Crispr And Crispr Associated Genes industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

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Crispr And Crispr Associated Genes Market 2020 | Growth Drivers, Challenges, Trends, Market Dynamics and Forecast to 2026 - Cole of Duty

Recommendation and review posted by Bethany Smith

1. FDA OKs first-ever use of gene-editing tool CRISPR to tackle Covid-19  Boston Business Journal
2. Feng Zhang's Sherlock gets first-ever CRISPR nod as FDA green-lights Covid-19 test kit  MedCity News
3. FDA Authorizes First-Ever Crispr Application For COVID-19 Coronavirus Test  Forbes
4. A COVID-19 diagnostic that uses CRISPR gets a nod from the FDA  Chemical & Engineering News
5. FDA authorizes CRISPR-based test for COVID-19  The Verge
6. View Full Coverage on Google News

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FDA OKs first-ever use of gene-editing tool CRISPR to tackle Covid-19 - Boston Business Journal

Recommendation and review posted by Bethany Smith

ZUG, Switzerland and CAMBRIDGE, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics, is scheduled to present at the virtual Bank of America Securities 2020 Health Care Conference on Thursday, May 14, 2020, at 11:40 a.m. ET.

A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company's website at https://crisprtx.com/events. A replay of the webcast will be archived on the Company's website for 14 days following the presentation.

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

Investor Contact:Susan Kimsusan.kim@crisprtx.com

Media Contact:Rachel Eides WCG on behalf of CRISPR617-337-4167reides@wcgworld.com

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CRISPR Therapeutics to Present at the Bank of America Securities 2020 Health Care Conference - Yahoo Finance UK

Recommendation and review posted by Bethany Smith

A team of researchers at the McGovern Institute for Brain Research at MIT, the Broad Institute of MIT and Harvard, the Ragon Institute, and the Howard Hughes Medical Institute (HHMI) has developed a new diagnostics platform called STOP (SHERLOCK Testing in One Pot) COVID. The test can be run in an hour as a single-step reaction with minimal handling, advancing the CRISPR-based SHERLOCK diagnostic technology closer to a point-of-care or at-home testing tool. The test has not been reviewed or approved by the FDA and is currently for research purposes only.

The team began developing tests for COVID-19 in January after learning about the emergence of a new virus which has challenged the healthcare system in China. The first version of the teams SHERLOCK-based COVID-19 diagnostics system is already being used in hospitals in Thailand to help screen patients for COVID-19 infection.

The new test is named STOPCovid and is based on the STOP platform. In research it has been shown to enable rapid, accurate, and highly sensitive detection of the COVID-19 virus SARS-CoV-2 with a simple protocol that requires minimal training and uses simple, readily-available equipment, such as test tubes and water baths.

STOPCovid has been validated in research settings using nasopharyngeal swabs from patients diagnosed with COVID-19. It has also been tested successfully in saliva samples to which SARS-CoV-2 RNA has been added as a proof-of-principle.

The team is posting the open protocol today on a new website, STOPCovid.science. It is being made openly available in line with the COVID-19 Technology Access Framework organized by Harvard, MIT, and Stanford. The Framework sets a model by which critically important technologies that may help prevent, diagnose, or treat COVID-19 infections may be deployed for the greatest public benefit without delay.

There is an urgent need for widespread, accurate COVID-19 testing to rapidly detect new cases, ideally without the need for specialized lab equipment. Such testing would enable early detection of new infections and drive effective test-trace-isolate measures to quickly contain new outbreaks. However, current testing capacity is limited by a combination of requirements for complex procedures and laboratory instrumentation and dependence on limited supplies. STOPCovid can be performed without RNA extraction, and while all patient tests have been performed with samples from nasopharyngeal swabs, preliminary experiments suggest that eventually swabs may not be necessary. Removing these barriers could help enable broad distribution.

The ability to test for COVID-19 at home, or even in pharmacies or places of employment, could be a game-changer for getting people safely back to work and into their communities, says Feng Zhang, a co-inventor of the CRISPR genome editing technology, an Investigator at the McGovern Institute for Brain Research and HHMI, and a Core Institute member at the Broad Institute. Creating a point-of-care tool is a critically important goal to allow timely decisions for protecting patients and those around them.

To meet this need, Zhang, McGovern Fellows Omar Abudayyeh and Jonathan Gootenberg, and colleagues initiated a push to develop STOPCovid. They are sharing their findings and packaging reagents so other research teams can rapidly follow up with additional testing or development. The group is also sharing data on the StopCOVID.science website and via a submitted preprint. The website is also a hub where the public can find the latest information on the teams developments.

STOPCovid is not yet approved by the FDA and is currently being used for research purposes.

How it works

The STOPCovid test combines CRISPR enzymes, programmed to recognize signatures of the SARS-CoV-2 virus, with complementary amplification reagents. This combination allows detection of as few as 100 copies of SARS-CoV-2 virus in a sample. As a result, the STOPCovid test allows for rapid, accurate, and highly sensitive detection of COVID-19 that can be conducted outside clinical laboratory settings.

STOPCovid has been tested on patient nasopharyngeal swab in parallel with clinically-validated tests. In these head-to-head comparisons, STOPCovid detected infection with 97% sensitivity and 100% specificity. Results appear on an easy-to-read strip that is akin to a pregnancy test, in the absence of any expensive or specialized lab equipment. Moreover, the researchers spiked mock SARS-CoV-2 genomes into healthy saliva samples and showed that STOPCovid is capable of sensitive detection from saliva, which would obviate the need for swabs in short supply and potentially make sampling much easier.

The test aims to ultimately be simple enough that anyone can operate it in low-resource settings, including in clinics, pharmacies, or workplaces, and it could potentially even be put into a turn-key format for use at home, says Omar Abudayyeh, McGovern Fellow at the McGovern Institute for Brain Research at MIT.

McGovern Fellow Jonathan Gootenberg adds, Since STOPCovid can work in less than an hour and does not require any specialized equipment, and if our preliminary results from testing synthetic virus in saliva bear out in patient samples, it could address the need for scalable testing to reopen our society.

Importantly, the full test both the viral genome amplification and subsequent detection can be completed in a single reaction, as outlined on the website, from swabs or saliva. To engineer this, the team tested a number of CRISPR enzymes to find one that works well at the same temperature needed by the enzymes that perform the amplification. Zhang, Abudayyeh, Gootenberg and their teams, including graduate students Julia Joung and Alim Ladha, settled on a protein called AapCas12b, a CRISPR protein from the bacterium Alicyclobacillus acidophilus, responsible for the off taste associated with spoiled orange juice. With AapCas12b, the team was able to develop a test that can be performed at a constant temperature and does not require opening tubes midway through the process, a step that often leads to contamination and unreliable test results.

Information sharing and next steps

The team has prepared reagents for 10,000 tests to share with scientists and clinical collaborators for free around the world who want to evaluate the STOPCovid test for potential diagnostic use, and they have set up the website STOPCovid.science to share the latest data and updates with the scientific and clinical community.

To learn more about the STOPCovid technology and point of care nucleic acid testing, visit STOPCovid.science. Kits and reagents can also be requested via a form on the website.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

*This article is based on research findings that are yet to be peer-reviewed. Results are therefore regarded as preliminary and should be interpreted as such. Find out about the role of the peer review process in researchhere. For further information, please contact the cited source.

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One-step Test Could Provide Rapid and Sensitive COVID-19 Detection - Technology Networks

Recommendation and review posted by Bethany Smith

Something's been brewing in the health care sector, the second-largest group in the S&P 500. Since the start of the second quarter, the Health Care Select Sector SPDR XLV, -0.01% is one of the top asset-gathering exchange traded funds.

The iShares Nasdaq Biotechnology ETF IBB, +0.13%, thanks to plenty of help from Gilead Sciences GILD, +0.18%, is up almost 14% over the past month. Much of the recent biotechnology ebullience is attributable to progress on the coronavirus treatment and vaccine front.

IBB is the largest biotechnology ETF by assets, but it's not the only one delivering impressive returns in recent weeks. Here's a trio of biotech ETFs that are knocking the cover off the ball.

Virtus LifeSci Biotech Clinical Trials ETF (BBC)

The Virtus LifeSci Biotech Clinical Trials ETF BBC, -0.05% tracks the LifeSci Biotechnology Clinical Trials Index. That benchmark is a collection of companies with drugs and therapies in clinical trials, which means BBC is at the right place at the right time in the battle to quash coronavirus.

BBC's holdings are basically equally weighted, but that doesn't distract from the fact that Moderna MRNA, +8.66% is the fund's top holding. Overall, BBC holds about 90 stocks, most of which dwell at the lower end of large-cap territory or are mid- or small-cap names.

In addition to Moderna, several other BBC components have coronavirus treatment exposure and roughly a dozen are credible takeover targets. That's enough to have BBC up nearly 27% over the past month.

ARK Genomic Revolution ETF (ARKG)

In the health care space, the ARK Genomic Revolution ETF (cboe:ARKG) has been one of the best-performing funds for several years, trouncing traditional health care and biotechnology ETFs for several years, speaking to the capabilities of the fund's active managers.

ARKG typically holds 30 to 50 stocks and currently holds 34, several of which are coronavirus plays and that doesn't even begin to underscore the fund's virus detection exposure, which highlights ARKG's deep CRISPR exposure.

As government officials re-open the US, testing for the COVID-19 virus will be a critical step. A new CRISPR-based test called DNA Endonuclease-Targeted CRISPR Trans Reporter (DETECTR) could help speed the process along, ARK analyst Ali Aurman saidin a recent note.

ARKG is higher by nearly 32% over the past month.

Principal Healthcare Innovators Index ETF (BTEC)

The Principal Healthcare Innovators Index ETF BTEC, +0.45% is a departure from the other funds mentioned here because it's not drug/therapy-centric. Rather, BTEC tilts more toward medical device, equipment and life sciences firms.

The fund invests in companies that are leading the charge toward innovative solutions, rather than spending money on marketing and distribution, according to Principal.

BTEC's nearly 210 holdings are considered research and development-intensive companies and the fund's methodology screens out companies with negative or inconsistent earnings. The fund is higher by almost 25% over the past month.

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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3 Biotech ETFs Up 10% Or More Over The Last Month - MarketWatch

Recommendation and review posted by Bethany Smith

Oakland, CA A young, female giraffe was brought to Oakland Zoo from Kansas City-based Lee Richardson Zoo on April 29. The move, prompted by a recommendation from the Association of Zoos and Aquariums Species Survival Plan to promote genetic diversity in captive giraffe, deemed Kijijis genetics an excellent match for Oakland Zoos male resident giraffe, Mabusu.

Kijijis 30-hour journey from Kansas City was handled by seasoned animal transport company, Premier Animal Logistics, and included frequent stops to check on her during the drive. A modified 136 tall trailer was used, with an enhanced interior for a safe and comfortable transport for the giraffe.

Kijiji is nearly two years old and eleven feet tall. She is still too young to have her own offspring, female giraffe typically show interest in breeding around 4 years of age. When that time comes, Oakland Zoos animal care team hope for a love connection between Kijiji and Mabusu, resulting in her becoming a first-time mother.

For the time being, Kijiji has met Oakland Zoos five other resident giraffe and was warmly welcomed into the herd.She is still learning her way around her new surroundings, and while she has been able to access the giraffe exhibit, she only chose to venture inside it this morning (May 7).For the past several days, she chose only to curiously look into the exhibit from a holding area.

Animal keepers have been watching and observing with quiet and excited anticipation and were thrilled to see her first steps into the exhibit to join the other giraffe today.

Kijiji is doing great. She was in good spirits upon her arrival to Oakland, and she has been eating well and exploring her surroundings. We can already see that she has a curious nature, and were thrilled to have her join our giraffe family, said Ann Marie Bisagno, Zoological Manager at Oakland Zoo Conservation Society of California.

By having giraffe at the zoo, the goal and hope is to bring appreciation and awareness to the giraffe species, including the challenges they face in the wild. Oakland Zoo partners with theReticulated Giraffe Projectin Kenya, a conservation organization dedicated to working with local communities in Africa to help reduce human-wildlife conflict and habitat loss in order to preserve endangered giraffe populations in the wild.

Short URL: http://www.vannuysnewspress.com/?p=37464

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Oakland Zoo Welcomes New Giraffe, Kijiji, To The Herd - Van Nuys News Press

Recommendation and review posted by Bethany Smith