Archive for the ‘Genetic Testing’ Category

Boston startup Orig3n logged hundreds of false-positives as it processed COVID-19 tests for dozens of Massachusetts long-term care facilities. According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to "human error" in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with Orig3n.

The consumer genetics startup, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples."

Upon retesting, all of the positive tests were found to be negative.

The spike in cases which turned out to be false positives caused panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before the Select Board.

Needham public health nurse Tiffany Zike told the board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

$25,000 wire transfer

In early May, nursing homes throughout Massachusetts were looking for a miracle.

The DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Mason, Ohio-based Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday that the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food and Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia and other public and private entities.

In late June, Link-age Solutions, which helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies, issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport neighborhood. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its startup status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

"Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs."

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, they're still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure you're not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how you're doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasn't being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if we're giving them the benefit of the doubt, they didn't know that there was a problem because otherwise it's just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but there's this strong culture where people recognize that their embarrassment is not worth a patient's hardship, Mina said. That's one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, they're also commonly fixed and they don't usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

It's just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I don't think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Trevor Ballantyne and Jeannette Hinkle are reporters for Gannett New England.

Originally posted here:
The sudden spike in Mass. COVID-19 cases was jarring. Now, the company that did the tests is under investigation. - The Gardner News

John Wagner was 38 when he was diagnosed with late stage colon cancer, a story that resembles the late Chadwick Boseman.

LOUISVILLE, Ky. The sudden death of actor Chadwick Boseman has everyone talking about colon cancer that ended his life at 43.

It's a reminder of the cancer risk that's rising among younger generations, even more so for Black men in this country.

This week, the American Cancer Society said it saw an 8,000% increase in traffic to its colorectal cancer symptoms page since Boseman's passing. It's a combination of colon and rectal cancers (CRC), often grouped together because they have many features in common.

"When I first figured out I had colon cancer, I was 38 years old," John Wagner said.

Wagner wasn't scheduled for a colonoscopy for another 6 years. He had no family history and considered himself a healthy guy, when he started feeling weak, having severe constipation and blood in his stool.

"He didn't smoke, or drink or do anything, and here you get this diagnosis, and you're like, wait. 'How did I get here?'" his fianc, Sharise Durrett said.

Multiple doctors sent him home without screening for cancer. At least one brushed it off as diverticulitis.

"I kept asking. They said, I was too young," said Wagner. "If it wasn't for that ER nurse, no telling what might have happened."

Durrett encouraged him to go to the ER where he received a colonoscopy. That's when they found the cancer. It had already spread to his liver.

Wagner's case is one of 145,000 new colorectal cases diagnosed in the U.S. every year. While the majority are in adults older than 50, it's the younger generation that's seen a rapid increase of cases over the last decade, and if you're Black, your risk is 20% higher than most, which increases even more for men, who are already 30% higher than women in the risk category.

The reasons are not clear, but doctors have general ideas.

"We know there are risk factors, like diet, exercise, smoking, obesity, and things like that, that play into this, but I think access plays a big part of that," Dr. Michael Driscoll, a medical oncologist, with Norton Cancer Institute said.

Insurance for most people, will only cover the costs of cancer screenings, if they're at or above the recommended age. For colon cancer, it's 45, unless you have a family history. In that case, screening should start earlier at age 40 or 10 years sooner than the age their relative was diagnosed.

"Any person with CRC under the age of 50 should also undergo genetic testing to make sure they are not dealing with a hereditary cause, such as Lynch Syndrome, which affects 1 in 279 of all races and both sexes," Dr. Whitney Jones, with the Colon Cancer Prevention Project said. "It's the most common cause of genetic colon cancer in America. Family history is critical."

"The colonoscopy is the gold standard," Dr. Driscoll said.

The problem: it's developing well before our golden years, and often times, has already spread before we start experiencing symptoms.

If this is happening to you, demand a test and nothing less.

"Colon cancer is 90 percent preventable," Dr. Driscoll said.

Still, close to 53,000 colon cancer patients will die this year. "Black Panther" star Chadwick Boseman was one of them.

"We were actually watching television together when it came on as breaking news," said Durrett. "It felt as if Chadwick was a member of our family because at that moment, John's life and Chadwick's life were parallel. There were so many similarities, it was scary."

She said the two sat in silence for the next 10 minutes. They know the numbers aren't in their favor.

People with Stage 4 Colon Cancer have less than a 10% survival rate.

"Ultimately, God has the final say," Durrett said.

But that's not stopping Wagner from trying.

"My goals are set high. I'm going to beat this. I can't let it get me down. There's no giving up," Wagner said.

In Kentucky, about 70% of people above the age of 50 get screened. It's about 68% in Indiana. Dr. Driscoll says that's not good enough.

Kentucky leads the nation in both under age 50 CRC incidence and overall CRC incidence. "But our screening rates are improving more rapidly than any state in the nation," Dr. Jones said. "Also, due to the long work of many organizations, screening rates and outcomes are equal for both blacks and whites. Our greatest disparity in outcomes is actually in Appalachia."

Kentucky state laws - by statute - in CRC screening coverage, follow the American Cancer Society guidelines, stating people with no family history of polyps or CRC can be covered for screenings at age 45. Medicaid's included.

Dr. Jones says, "on-time screening at age 45 with a colonoscopy or home stool tests (FIT or stool DNA, Cologuard) will save many lives if we can get the word out. Choice gets more people engaged in screening due to shared decision making."

Contact reporter Brooke Hasch atbhasch@whas11.com. Follow her onTwitter (@WHAS11Hasch)andFacebook.

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Link:
'I kept asking, they said I was too young' | The risks of colon cancer - WATN - Local 24

However, the chances of taking home a baby are still largely dependent on a woman's age and the IVF clinics treating them. Individual clinic success rates range between 7 per cent and 31 per cent of cycles.

There were 14,355 babies born via IVF from 76,341 IVF cycles in 2018 according to the report collated by the National Perinatal Epidemiology and Statistics Unit at UNSW and funded by the FSA. This is up from 13,752 IVF babies in 2017.

The report covers all IVF cycles undertaken in Australian and New Zealand clinics in 2018 and the resulting babies born in 2018 and 2019.

IVF clinics are increasingly doing "freeze-all" cycles, in which all the eggs or embryos collected in a cycle are cryopreserved rather than transferring a fresh embryo.

The proportion of freeze-all cycles doubled in five years from 13 per cent to 26.7 per cent in 2018.

Professor Rombauts said the main driver of the freeze-all trend was the rise in pre-implantation genetic testing, in which embryos are screened for chromosomal abnormalities in the hope of selecting only the healthy embryos to transfer.

"For women over 35 in particular genetic screening can be beneficial, when there is a higher risk of abnormalities," he said.

"Genetic testing can reduce the time, money, energy and trauma it takes to have a healthy live birth because you're potentially not transferring embryos that are doomed to fail."

However, growing evidence suggests there could be a small risk that pre-implantation genetic testing could lead to viable embryos being discarded by incorrectly flagging them as abnormal.

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"For women under 35 I would certainly not recommend it it's an extra manipulation on the embryos and an extra cost," Professor Rombauts said. "But for older women, it can be an important test and I would raise it as an option because there is potential benefit."

Laura Smith, 34, from Forest Lodge is the proud mother of 4-month-old Hunter after undergoing IVF at Genea. "For me, he's perfection and everything I ever wanted," she said.

Ms Smith, who has polycystic ovarian syndrome, and her husband Ben spent a couple of years trying to conceive naturally then about a year trying other fertility treatment before turning to IVF.

Her eggs were harvested in one cycle and the embryo that became Hunter implanted a month later, while the others are frozen for future use. The couple intend to try for a second child fairly quickly.

It's an absolutely fantastic thing that we've been given this technology ... who knows if I would have had a baby by now if I didn't have IVF?

"I was very lucky I fell pregnant the very first round of IVF and I had no complications or issues," Ms Smith said. "It's an absolutely fantastic thing that we've been given this technology and the ability to be able to have babies in this way who knows if I would have had a baby by now if I didn't have IVF?"

She opted to use a frozen embryo because of medical advice it would improve her odds to harvest and implant on different cycles and to enable genetic testing.

IVF clinics are reporting dramatic differences in their success rates. One clinic had a live birth rate of roughly 7 per cent of initiated cycles, compared to 31.5 per cent at the clinic with the highest success rate.

The clinics were not identified in the report and should be interpreted with caution. For instance, some clinics may specialise in second referrals for complex patients, older women, or younger, uncomplicated cases.

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A new federal-government-funded website will soon give would-be parents access to individual clinic success rates and their own chances of taking home a baby after undergoing IVF based on their individual characteristics.

The 'My IVF Success' website is expected to be ready to launch before the end of the year in response to growing calls for greater transparency in the sector.

Age is still a powerful determiner of IVF success, with younger women having better chances. For women under 30 years, live birth rate per fresh embryo transfer was 40.4 per cent compared to 9.5 per cent for women aged 40 to 44.

For frozen embryo transfers, the live birth rate was 34.9 per cent in women under 30, and 20.1 per cent for women aged 40 to 44.

Professor Georgina Chambers, the report's lead author and Director of UNSW's National Perinatal Epidemiology and Statistics Unit said the higher live birth rate for older women via frozen cycles was mostly because the embryo was created in an earlier fresh cycle when she was younger.

"It's also because we're increasingly using pre-implantation genetic testing to select the healthy embryos for transfer rather than putting back embryos that aren't viable," Professor Chambers said.

In 2018, the average age of women using their own eggs was 35.8 years about five years older than the median age at which women, in general, gave birth in Australia (30.7 years).

The average age of women using donor eggs or embryos was 40 and the average age of male partners of women undergoing IVF was 38.1 years old.

The proportion of twins and triplets born via IVF treatment is now a record low 3.2 per cent in Australia and New Zealand thanks to the decrease in multiple embryo transfers in the one cycle.

with Caitlin Fitzsimmons

Kate Aubusson is Health Editor of The Sydney Morning Herald.

More here:
'Quite amazing': One in 10 babies born to women over 35 now conceived via IVF - Sydney Morning Herald

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Market Analysis and Insights: Global Preimplantation Genetic Testing Market

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Some Points from TOC:

1 Study Coverage1.1 Preimplantation Genetic Testing Product Introduction1.2 Market Segments1.3 Key Preimplantation Genetic Testing Manufacturers Covered: Ranking by Revenue1.4 Market by Type1.4.1 Global Preimplantation Genetic Testing Market Size Growth Rate by Type1.4.2 Type 11.4.3 Type 21.4.4 Type 31.4.5 Others1.5 Market by Application1.5.1 Global Preimplantation Genetic Testing Market Size Growth Rate by Application1.5.2 Application 11.5.3 Application 21.5.4 Application 31.5.5 Others1.6 Study Objectives1.7 Years Considered

2 Executive Summary2.1 Global Preimplantation Genetic Testing Market Size, Estimates and Forecasts2.1.1 Global Preimplantation Genetic Testing Revenue 2015-20262.1.2 Global Preimplantation Genetic Testing Sales 2015-20262.2 Global Preimplantation Genetic Testing, Market Size by Producing Regions: 2015 VS 2020 VS 20262.2.1 Global Preimplantation Genetic Testing Retrospective Market Scenario in Sales by Region: 2015-20202.2.2 Global Preimplantation Genetic Testing Retrospective Market Scenario in Revenue by Region: 2015-2020

3 Global Preimplantation Genetic Testing Competitor Landscape by Players3.1 Preimplantation Genetic Testing Sales by Manufacturers3.2 Preimplantation Genetic Testing Revenue by Manufacturers3.3 Preimplantation Genetic Testing Price by Manufacturers3.4 Preimplantation Genetic Testing Manufacturing Base Distribution, Product Types3.5 Manufacturers Mergers & Acquisitions, Expansion Plans

4 Market Size by Type (2015-2026)4.1 Global Preimplantation Genetic Testing Market Size by Type (2015-2020)4.2 Global Preimplantation Genetic Testing Market Size Forecast by Type (2021-2026)4.3 Global Preimplantation Genetic Testing Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End

5 Market Size by Application (2015-2026)5.1 Global Preimplantation Genetic Testing Market Size by Application (2015-2020)5.2 Preimplantation Genetic Testing Market Size Forecast by Application (2021-2026)

6 North America6.1 North America Preimplantation Genetic Testing by Country6.1.1 North America Preimplantation Genetic Testing Sales by Country6.1.2 North America Preimplantation Genetic Testing Revenue by Country6.1.3 U.S.6.1.4 Canada6.2 North America Preimplantation Genetic Testing Market Facts & Figures by Type6.3 North America Preimplantation Genetic Testing Market Facts & Figures by Application

7 Europe7.1 Europe Preimplantation Genetic Testing by Country7.1.1 Europe Preimplantation Genetic Testing Sales by Country7.1.2 Europe Preimplantation Genetic Testing Revenue by Country7.1.3 Germany7.1.4 France7.1.5 U.K.7.1.6 Italy7.1.7 Russia7.2 Europe Preimplantation Genetic Testing Market Facts & Figures by Type7.3 Europe Preimplantation Genetic Testing Market Facts & Figures by Application

8 Asia Pacific.

11 Company Profiles11.1 Company Profiles 111.1.1 Company Profiles 1 Corporation Information11.1.2 Company Profiles 1 Description and Business Overview11.1.3 Company Profiles 1 Sales, Revenue and Gross Margin (2015-2020)11.1.4 Company Profiles 1 Preimplantation Genetic Testing Products Offered11.1.5 Company Profiles 1 Related Developments

11.2 Company Profiles 211.2.1 Company Profiles 2 Corporation Information11.2.2 Company Profiles 2 Description and Business Overview11.2.3 Company Profiles 2 Sales, Revenue and Gross Margin (2015-2020)11.2.4 Company Profiles 2 Preimplantation Genetic Testing Products Offered11.2.5 Company Profiles 2 Related Developments

11.3 Company Profiles 311.3.1 Company Profiles 3 Corporation Information11.3.2 Company Profiles 3 Description and Business Overview11.3.3 Company Profiles 3 Sales, Revenue and Gross Margin (2015-2020)11.3.4 Company Profiles 3 Preimplantation Genetic Testing Products Offered11.3.5 Company Profiles 3 Related Developments

11.4 Company Profiles 411.4.1 Company Profiles 4 Corporation Information11.4.2 Company Profiles 4 Description and Business Overview11.4.3 Company Profiles 4 Sales, Revenue and Gross Margin (2015-2020)11.4.4 Company Profiles 4 Preimplantation Genetic Testing Products Offered11.4.5 Company Profiles 4 Related Developments

11.5 Company Profiles 511.5.1 Company Profiles 5 Corporation Information11.5.2 Company Profiles 5 Description and Business Overview11.5.3 Company Profiles 5 Sales, Revenue and Gross Margin (2015-2020)11.5.4 Company Profiles 5 Preimplantation Genetic Testing Products Offered11.5.5 Company Profiles 5 Related Developments.13 Market Opportunities, Challenges, Risks and Influences Factors Analysis13.1 Market Opportunities and Drivers13.2 Market Challenges13.3 Market Risks/Restraints13.4 Porters Five Forces Analysis13.5 Primary Interviews with Key Preimplantation Genetic Testing Players (Opinion Leaders)

14 Value Chain and Sales Channels Analysis14.1 Value Chain Analysis14.2 Preimplantation Genetic Testing Customers14.3 Sales Channels Analysis14.3.1 Sales Channels14.3.2 Distributors

15 Research Findings and ConclusionContinued.

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Preimplantation Genetic Testing Market 2020| Share, Size, Increasing Rapidly with Recent Trends, Growth, Revenue, Demand and Forecast to 2026 -...

September 2, 2020 An international, first-of-its-kind cardiology trial used personalized genetic testing to reduce by 34 per cent the number of serious adverse events following balloon angioplasty, a treatment for the most common form of heart disease.

For patients undergoing percutaneous coronary intervention (PCI), the choice of antiplatelet therapy can be critical to post treatment success, and to minimize the chance of heart attack or stroke.

The TAILOR-PCI trial, co-led by principal investigators Michael Farkouh, M.D., cardiologist and Multinational Clinical Trials Chair at the Peter Munk Cardiac Centre and director of the Heart and Stroke/Richard Lewar Centre of Excellence in Cardiovascular Research, University of Toronto, and Naveen Pereira, M.D., professor of medicine and cardiologist at Mayo Clinic, studied the effectiveness of genetic-guided therapy in patients that have had PCIs when compared to conventional therapy.

The trial introduces the concept and validates the approach to personalized medicine when it comes to antiplatelet therapy, and therefore allows our physicians to potentially change their practice based on the needs of patients undergoing PCI, Farkouh said. This will potentially inform the kinds of therapies patients with heart disease are prescribed after PCI world-wide.

Placement of a balloon and metal stent inside a heart artery can irritate the blood vessel and cause it to clot, which can block the artery from being treated. PCI patients are prescribed medications to prevent their blood from clotting the most common medication used is clopidogrel, which stops blood platelets from sticking together and prevents clots from forming. However, in almost a third of all patients, the gene (CYP2C19) required to activate clopidogrel does not work.

As a result, patients with this genetic variant may be at a higher risk of experiencing adverse cardiovascular events, such as heart attack or stroke in the year following their procedure.

Current guidelines do not recommend genetic testing when prescribing clopidogrel, and the trial was designed to determine if genetic testing would decrease cardiovascular complications after PCI.

The Journal of the American Medical Association (JAMA) published the results of the TAILOR-PCI trial on Aug. 25, 2020.[1] The trial enrolled 5,302 patients treated for heart artery blockage with one or more stents, and followed them for one year.

Half the group was tested for the CYP2C19 gene variation, and carriers (35%) were treated with the alternative anti-platelet medication, Ticagrelor. The remainder of the group was given Clopidogrel, as was the entire control group of patients who did not receive genetic testing before PCI.

Although the TAILOR-PCI trial did not meet its primary endpoint of demonstrating a 50 per cent reduction at one-year post-procedure, trends did show a benefit towards genetic testing with a 34 per cent reduction in serious adverse cardiovascular events.

Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one third fewer adverse events in the patients who received genetically guided treatment compared with those who did not, Pereira said.

A post-hoc analysis of the trial also showed a nearly 80% reduction in the rate of adverse events in the first three months of treatment among patients who received genetically guided therapy compared with those who did not.

Since the studys design in 2012, the standard of care following PCIs has greatly improved. Drug-coated stents and other treatments have reduced the rate of adverse events for patients in a year, but at the same time made it more difficult for the trial to reach its goal.

The trial is currently undergoing an extended follow-up beyond the original 12-month period.

The study was funded by Mayo Clinic, Mayo Clinic Center for Individualized Medicine and the National Heart, Lung and Blood Institute. Spartan Bioscience Inc. supplied the point-of-care genetic tests used.

Find more news on antiplatelet therapies

Reference:

1. Naveen L. Pereira, Michael E. Farkouh, Derek So, et al. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary InterventionThe TAILOR-PCI Randomized Clinical Trial. JAMA. 2020;324(8):761-771. doi:10.1001/jama.2020.12443.

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Trial Shows Benefit of Using Genetic Testing to Tailor Antiplatelet Therapy - Diagnostic and Interventional Cardiology

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results, including some in Fall River and Taunton.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to human error in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with the company, Orig3n.

The consumer genetics start-up, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples.

Upon retesting, all of the positive tests were found to be negative.

The spike in cases -- which turned out to be false positives -- caused a panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before its Select Board.

Needham Public Health Nurse Tiffany Zike told the Board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

A $25,000 wire transfer

In early May, nursing homes across Massachusetts were looking for a miracle.

The Massachusetts DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of the $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the Massachusetts DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food & Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia, and other public and private entities.

In late June, Link-age Solutions, a Mason, Ohio-based company that helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its start-up status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were, working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it, habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs.

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said, human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, theyre still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure youre not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how youre doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasnt being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if were giving them the benefit of the doubt, they didnt know that there was a problem because otherwise its just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but theres this strong culture where people recognize that their embarrassment is not worth a patients hardship, Mina said. Thats one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, theyre also commonly fixed and they dont usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

Its just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I dont think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Continue reading here:
Genetics start-up continues COVID-19 testing as DPH probes testing errors, including some in Fall River, Taunton - Taunton Daily Gazette

SAN FRANCISCO, Sept. 3, 2020 /PRNewswire/ --Invitae (NYSE: NVTA), a leading medical genetics company, today announced enrollment has begun for a nationwide study to better understand the role of current genetic testing guidelines in ensuring prostate cancer patients receive testing to identify clinically relevant genetic variants that can inform prognosis and support access to targeted therapies. The study is supported by Invitae and is part of the company's ongoing work to increase access to genetic information for men with prostate cancer.

"Currently, germline testing guidelines for patients with prostate cancer have evolved from more than one set of NCCN guidelines and some may still find these guidelines difficult to implement in everyday practice," said Neal D. Shore, M.D., F.A.C.S. from the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and the principal investigator of the study. "Guidelines were established when testing was both more expensive and less accessible and don't address newer therapeutic approvals and trial literature for expanding therapeutic options, missing many patients whose clinical care and treatment choices could benefit from genetic information. Our study is intended to provide a deeper understanding of how these issues impact the care of men with prostate cancer so that we might improve how genetic information can be assessed and utilized for their cancer care and potentially inform their family members."

The use and importance of genetic information in the diagnosis and treatment of prostate cancer has been growing, particularly as the development of targeted treatments continues to accelerate. Despite its utility, guidelines governing testing among prostate cancer patients remain restrictive, and genetic information is underutilized in prostate cancer care. The study will determine whether guidelines are adequate in identifying patients who may benefit from genetic testing.

"Simplifying and possibly expanding current testing guidelines would provide benefits for medical management of men with prostate cancer and offer opportunities for targeted therapies, including PARP inhibitors and qualification for clinical trials," said Robert Nussbaum, M.D., chief medical officer of Invitae. "In addition, the genes involved in prostate cancer include BRCA1 and 2, which as we all know also play an important role in breast and ovarian cancer, and MSH6 and other genes involved in hereditary colon cancer. Widespread testing among men with prostate cancer could have an important role in not only improving their care but also the health of their relatives."

The study will enroll men across the country who have been diagnosed with prostate cancer. Both men who meet and don't meet current testing guidelines will be included to gather data on whether genetic testing results change treatment and recommendations. In addition, the study will also gather data on the patient's experience with genetic testing.

A study presented recentlyby Invitae at the American College of Medical Genetics and Genomics (ACMG) underscored the frequency of actionable variants expanded testing can help uncover. The study of 2,252 men found an overall positive rate of 13% with no statistical differences in rates among stages of disease. Only half of patients with an actionable variant reported a family history suggestive of increased risk. Nearly three-quarters (71%) of positive patients were eligible for management guidelines and/or potentially eligible for approved precision therapies or clinical trials.

An estimated three million men are living with prostate cancer in the U.S., and just under 200,000 are newly diagnosed each year.

Contact [emailprotected] for more information about the study.

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 atinvitae.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 the use and importance of genetic testing and information; and the benefits of simplifying and possibly expanding current testing guidelines for men with prostate cancer. 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 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 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 filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact:Laura D'Angelo[emailprotected](628) 213-3283

SOURCE Invitae Corporation

http://www.invitae.com

Excerpt from:
Multi-site study to evaluate the role of testing guidelines in ensuring access to genetic information for men with prostate cancer - PRNewswire

TEMPLE CITY, Calif., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics (Nasdaq: FLGT) and New York City Health and Hospitals have announced they will provide COVID-19 testing to hundreds of thousands of students across approximately 1600 locations as they return to school in September and over the next several months. Fulgent will provide its FDA EUA-approved at-home test, Picture by Fulgent, a RT-PCR test that provides the highest level of sensitivity and specificity, utilizing a self-collected nasal swab sample. Fulgent will provide results within 24-48 hours from the time when Fulgent receives and accepts a specimen for the test.

Fulgent is very happy to partner with the City of New York on such an important and novel testing protocol. Its an ambitious goal to test so many students in such a rapid fashion, but the combination of the Fulgent technology platform and lab capacity along with the strong testing infrastructure of New York City makes this possible, commented Brandon Perthuis, Chief Commercial Officer of Fulgent Genetics. In just a few short days, we were able to get the first shipment of hundreds of thousands of Picture kits to New York City. We will now be working closely with the city on the distribution, return and replenishment of the kits, added Perthuis.

This is one of the first large-scale testing programs for COVID-19 to utilize an at-home test kit. Fulgents Picture Genetics at-home test was chosen due to its convenient self-administration, which can be used on-site at schools as well as at home. The companys industry-leading turnaround time of 24-48 hours also makes this a powerful tool for back-to-school testing.

About NYC Test & Trace Corps

The NYC Test & Trace Corps is a public health initiative to fight COVID-19 so that New Yorkers can get back to school, work and help New York City reopen safely. The Corps is a group of doctors, public health professionals and community advocates working to reverse the COVID-19 outbreak and protect our city. The public health program is led by NYC Health + Hospitals in close collaboration with the NYC Department of Health and Mental Hygiene and other city agencies. Through its robust and citywide partnerships, The Corps helps New Yorkers receive free, safe and confidential testing for COVID-19 and for the antibody test. It ensures that anyone with the virus receives care and can safely isolate to prevent the spread. For more information, visit https://www.nychealthandhospitals.org/test-and-trace/.

About Fulgent Genetics

Fulgent Genetics proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy and competitive turnaround times. Combining next generation sequencing (NGS) with its technology platform, the Company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. In 2019, the Company launched its first patient-initiated product, Picture Genetics, a new line of at-home screening tests that combines the Companys advanced NGS solutions with actionable results and genetic counseling options for individuals. Since March 2020, the Company has commercially launched several tests for the detection of SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19), including NGS and reverse transcription polymerase chain reaction (RT-PCR) - based tests. The Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the RT-PCR-based tests for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs) and for the at-home testing service through Picture Genetics. A cornerstone of the Companys business is its ability to provide expansive options and flexibility for all clients unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

About Picture Genetics

Through its Picture Genetics platform launched in 2019, Fulgent Genetics offers consumers direct access to its advanced genetic testing and analytics capabilities from the ease and comfort of home, at an affordable price point. The Picture Genetics platform provides a holistic approach to at-home genetic screening by including oversight from independent physicians as well as genetic counseling options to complement Fulgent Genetics comprehensive genetic testing analysis. The Picture Genetics platform currently offers multiple tests, providing medically actionable, clinical-level results with professional medical follow-up in one easy process. Visit http://www.picturegenetics.comfor more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: the companys identification and evaluation of opportunities and its ability to capitalize on opportunities to grow its business; expected future lab capacity and turnaround times; expectations or guidance regarding future revenues and managements judgements and evaluations of the companys platform and technology.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the companys future performance, and they are based on managements current assumptions, expectations and beliefs concerning future developments and their potential effect on the companys business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemics effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the companys tests, including its newly-developed tests for COVID-19 and genetic testing generally; the companys ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the companys ability to maintain the low internal costs of its business model, particularly as the company makes investments across its business; the companys ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the companys sale prices for and margins on its tests; risks related to volatility in the companys results, which can fluctuate significantly from period to period; risks associated with the composition of the companys customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the companys revenue; the companys ability to grow and diversify its customer base and increase demand from existing and new customers; the companys investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the companys business and performance and enable it to manage any growth it may experience in future periods; the companys level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the companys level of success in establishing and obtaining the intended benefits from partnerships, joint ventures or other relationships; the companys compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the companys international operations; the companys ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The companys reports filed with the U.S. Securities and Exchange Commission (SEC), including its annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the companys website upon their filing with the SEC. These reports contain more information about the company, its business and the risks affecting its business.

Investor Relations Contact:The Blueshirt GroupMelanie Solomon, 415-217-4964, melanie@blueshirtgroup.com

Media Contact:The Blueshirt GroupJeff Fox, 415-828-8298, jeff@blueshirtgroup.com

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Fulgent Genetics, New York City Health and Hospitals Partner on Large-Scale Back-to-School COVID-19 Testing - GlobeNewswire

TEMPLE CITY, Calif., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) (Fulgent Genetics or the company), a technology company providing comprehensive testing solutions through its scalable technology platform, today announced that its Chairman and Chief Executive Officer Ming Hsieh, Chief Financial Officer Paul Kim, and Chief Commercial Officer Brandon Perthuis are scheduled to virtually participate in the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020. These representatives of the company will host a presentation beginning at 1:00 p.m. ET.

A live webcast of the presentation will be available on the Investor Relations section of the Fulgent Genetics website at ir.fulgentgenetics.com. A replay of the webcast will be accessible on the Events section of the IR website beginning approximately one hour following the completion of the event.

About Fulgent Genetics

Fulgent Genetics proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy and competitive turnaround times. Combining next generation sequencing (NGS) with its technology platform, the Company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. In 2019, the Company launched its first patient-initiated product, Picture Genetics, a new line of at-home screening tests that combines the Companys advanced NGS solutions with actionable results and genetic counseling options for individuals. Since March 2020, the Company has commercially launched several tests for the detection of SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19), including NGS and reverse transcription polymerase chain reaction (RT-PCR) - based tests. The Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the RT-PCR-based tests for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs) and for the at-home testing service through Picture Genetics. A cornerstone of the Companys business is its ability to provide expansive options and flexibility for all clients unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

About Picture Genetics

Through its Picture Genetics platform launched in 2019, Fulgent Genetics offers consumers direct access to its advanced genetic testing and analytics capabilities from the ease and comfort of home, at an affordable price point. The Picture Genetics platform provides a holistic approach to at-home genetic screening by including oversight from independent physicians as well as genetic counseling options to complement Fulgent Genetics comprehensive genetic testing analysis. The Picture Genetics platform currently offers multiple tests, providing medically actionable, clinical-level results with professional medical follow-up in one easy process. Visit http://www.picturegenetics.com for more information.

Investor Relations Contact:The Blueshirt GroupMelanie Solomon, 415-217-4964, melanie@blueshirtgroup.com

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Fulgent Genetics to Participate in the H.C. Wainwright 22nd Annual Global Investment Conference - GlobeNewswire

Global Genetic Testing Services Marketis a well-synchronized synopsis of the market, highlighting real-time research analysis that enables quick and efficient business preference. The report delivers valuable data with the aid of fragmenting the market into different segments. The report is a quick reference point which enhances reader understanding of the volatile market situations that collectively drive broad growth opportunities in the globalGenetic Testing Servicesmarket. Various vital elements are covered in the global market research report, including regional industry perspectives, geographic developments, country-level assessment, competitive environment, market share analysis of companies.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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The report also includes information for the next five years as forested data and the past five years as past data and the market share of several key information. Major players within this globalGenetic Testing Servicesmarket are explored with their company profile, product specifications, capacity, production value, and market shares for each company. Additional details covered in this report include company description, major business, company total revenue, and the production capacity, price, revenue generated in business, product introduction, recent developments, etc.

Top key players profiled in this report:Laboratory Corporation of America Holdings, Genomic Health, Inc., NeoGenomics Laboratories, Inc., Quest Diagnostics Incorporated, Eurofins Scientific, Ambry Genetics, Hoffmann-La Roche Ltd, Illumina, Inc., CENTOGENE AG, 23andMe, Sequenom, GeneDx, Abbott, Cepheid Inc., and others.

Region Analysis: The report then estimates 2020-2025 market development trends of the globalGenetic Testing Servicesmarket. The study has added the analysis of upstream raw materials, downstream demand, and current market dynamics. Finally, the report makes some important proposals for a new project of the market before evaluating its feasibility.

Geographically regions covered in this report:North America, Europe, Asia Pacific, South America, and the Middle East and Africa.

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Global Genetic Testing Services Market 2020 with Covid-19 Impact Analysis and Forecast by 2025 - Good Night, Good Hockey

Genetic Testing Industry Market report 2020, discourses numerous driving factors or restraining the market, which will help the future market to raise with a huge CAGR. The Genetic Testing Market research Reports offers an all-encompassing collection of reports on different markets covering essential details. The Genetic Testing Market report studies the viable environment of the Genetic Testing Market is based on company profiles and their efforts on growing product value and production.

As per the findings of the presented study, the Genetic Testing Market is poised to exceed the value of ~US$ XX by the end of 2026 emergent at a CAGR of ~XX% over the assessment period.

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Major Key Players:

HI GeneRegulatoryAnnoroadSinoGenoMaxGenePlanetCounsyl, Inc.RepconexNatera, IncBiomarkerGeeppine360Jiyin23andMe, IncCapitalBioBiomedlabGene by GeneUnited GeneGeneDxFind Bio-TechAiyin GeneCourtagen Life SciencesAgenGeneTestsAsper BiotechPathway GenomicsNovogeneBGIGene KangBerry GenomicsAijiyin

Geographically Regions covered in this report:

Segment by Type

CancerCystic fibrosisSickle cell anemiaDuchenne muscular dystrophyAlzheimer diseaseThalassemiaHuntington diseaseOthers

Segment by Application:

Newborn screeningDiagnostic testingCarrier testingPreimplantation genetic diagnosisPrenatal diagnosisPredictive and presymptomatic testingPharmacogenomics

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The competitive analysis included in the global Genetic Testing Market study allows their readers to know the difference between players. The Genetic Testing research study gives an in-deep insight on the up-to-date trends of the market along with the opportunities for the new players in arriving global Genetic Testing Market. The readers of the Genetic Testing Market report also provide numerous key insights such as market size, Products, and application along with their market share and growth rate. The report also includes information for the next five years as forested data and the past five years as past data and the market share of several key information.

The Genetic Testing Market Report offers SWOT examination and venture return investigation, and other aspects of financial situations with benefit, generation, request, limit, supply, and market development rate and figure.

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Genetic Testing Market Report Structure:

Report Highlights:

The report has 150 tables and figures browse the report description and TOC:

Table of Contents

1 Genetic Testing Market Study Coverage

1.1 Genetic Testing Product

1.2 Key Market Segments in This Genetic Testing Study

1.3 Key Manufacturers Covered

1.4 Genetic Testing Market by Type

1.4.1 Global Genetic Testing Market Size Growth Rate by Type

1.5 Genetic Testing Market by Application

1.5.1 Global Genetic Testing Size Growth Rate by Application

2 Executive Summary

2.1 Global Genetic Testing Market Size

2.1.1 Global Genetic Testing Revenue 2014-2026

2.1.2 Global Genetic Testing Production 2014-2026

2.2 Genetic Testing Growth Rate (CAGR) 2020-2026

2.3 Genetic Testing Market Analysis of Modest Landscape

2.3.1 Manufacturers Market Concentration Ratio

2.3.2 Key Genetic Testing Manufacturers

2.3.2.1 Genetic Testing Manufacturing Base Distribution, Headquarters

2.3.2.2 Genetic Testing Product Offered

2.3.2.3 Date of Manufacturers in Genetic Testing Market

2.4 Key Trends for Genetic Testing Markets & Products

3 Market Size by Manufacturers

3.1 Genetic Testing Production by Manufacturers

3.1.1 Genetic Testing Production by Manufacturers

3.1.2 Genetic Testing Production Market Share by Manufacturers

3.2 Genetic Testing Revenue by Manufacturers

3.2.1 Genetic Testing Revenue by Manufacturers (2020-2026)

3.2.2 Genetic Testing Revenue Share by Manufacturers (2020-2026)

3.3 Genetic Testing Price by Manufacturers

3.4 Mergers & Acquisitions, Expansion Plans

More Information.

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Global Genetic Testing Market Key Companies are studied in a Latest Report and Forecast to 2026 - Scientect

John Wagner was 38 when he was diagnosed with late stage colon cancer, a story that resembles the late Chadwick Boseman.

LOUISVILLE, Ky. The sudden death of actor Chadwick Boseman has everyone talking about colon cancer that ended his life at 43.

It's a reminder of the cancer risk that's rising among younger generations, even more so for Black men in this country.

This week, the American Cancer Society said it saw an 8,000% increase in traffic to its colorectal cancer symptoms page since Boseman's passing. It's a combination of colon and rectal cancers (CRC), often grouped together because they have many features in common.

"When I first figured out I had colon cancer, I was 38 years old," John Wagner said.

Wagner wasn't scheduled for a colonoscopy for another 6 years. He had no family history and considered himself a healthy guy, when he started feeling weak, having severe constipation and blood in his stool.

"He didn't smoke, or drink or do anything, and here you get this diagnosis, and you're like, wait. 'How did I get here?'" his fianc, Sharise Durrett said.

Multiple doctors sent him home without screening for cancer. At least one brushed it off as diverticulitis.

"I kept asking. They said, I was too young," said Wagner. "If it wasn't for that ER nurse, no telling what might have happened."

Durrett encouraged him to go to the ER where he received a colonoscopy. That's when they found the cancer. It had already spread to his liver.

Wagner's case is one of 145,000 new colorectal cases diagnosed in the U.S. every year. While the majority are in adults older than 50, it's the younger generation that's seen a rapid increase of cases over the last decade, and if you're Black, your risk is 20% higher than most, which increases even more for men, who are already 30% higher than women in the risk category.

The reasons are not clear, but doctors have general ideas.

"We know there are risk factors, like diet, exercise, smoking, obesity, and things like that, that play into this, but I think access plays a big part of that," Dr. Michael Driscoll, a medical oncologist, with Norton Cancer Institute said.

Insurance for most people, will only cover the costs of cancer screenings, if they're at or above the recommended age. For colon cancer, it's 45, unless you have a family history. In that case, screening should start earlier at age 40 or 10 years sooner than the age their relative was diagnosed.

"Any person with CRC under the age of 50 should also undergo genetic testing to make sure they are not dealing with a hereditary cause, such as Lynch Syndrome, which affects 1 in 279 of all races and both sexes," Dr. Whitney Jones, with the Colon Cancer Prevention Project said. "It's the most common cause of genetic colon cancer in America. Family history is critical."

"The colonoscopy is the gold standard," Dr. Driscoll said.

The problem: it's developing well before our golden years, and often times, has already spread before we start experiencing symptoms.

If this is happening to you, demand a test and nothing less.

"Colon cancer is 90 percent preventable," Dr. Driscoll said.

Still, close to 53,000 colon cancer patients will die this year. "Black Panther" star Chadwick Boseman was one of them.

"We were actually watching television together when it came on as breaking news," said Durrett. "It felt as if Chadwick was a member of our family because at that moment, John's life and Chadwick's life were parallel. There were so many similarities, it was scary."

She said the two sat in silence for the next 10 minutes. They know the numbers aren't in their favor.

People with Stage 4 Colon Cancer have less than a 10% survival rate.

"Ultimately, God has the final say," Durrett said.

But that's not stopping Wagner from trying.

"My goals are set high. I'm going to beat this. I can't let it get me down. There's no giving up," Wagner said.

In Kentucky, about 70% of people above the age of 50 get screened. It's about 68% in Indiana. Dr. Driscoll says that's not good enough.

Kentucky leads the nation in both under age 50 CRC incidence and overall CRC incidence. "But our screening rates are improving more rapidly than any state in the nation," Dr. Jones said. "Also, due to the long work of many organizations, screening rates and outcomes are equal for both blacks and whites. Our greatest disparity in outcomes is actually in Appalachia."

Kentucky state laws - by statute - in CRC screening coverage, follow the American Cancer Society guidelines, stating people with no family history of polyps or CRC can be covered for screenings at age 45. Medicaid's included.

Dr. Jones says, "on-time screening at age 45 with a colonoscopy or home stool tests (FIT or stool DNA, Cologuard) will save many lives if we can get the word out. Choice gets more people engaged in screening due to shared decision making."

Contact reporter Brooke Hasch atbhasch@whas11.com. Follow her onTwitter (@WHAS11Hasch)andFacebook.

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'I kept asking, they said I was too young' | The risks of colon cancer - FirstCoastNews.com WTLV-WJXX

SPRINGFIELD - Dr. Nada Kawar, who represented her native Jordan in the shot put both at the 1996 and 2000 Olympic games, had plans to be an orthopedic surgeon.

However, a rotation in obstetrics and gynecology in her third year of medical school at Washington University in St. Louis, Missouri, changed her focus to womens health. She went on to a residency in obstetrics and gynecology at University of California San Francisco Medical Center and a fellowship in gynecologic oncology and breast surgery at Brown University/Women and Infants Hospital of Rhode Island that taught her how entwined breast and gynecologic cancers can be.

Her extensive training as a gynecologic oncologist she is board certified in obstetrics and gynecology and gynecologic oncology, and certified in breast disease as well as breast surgery and in the fundamentals of laparoscopic surgery qualifies her to both diagnose as well as provide surgical and medical treatment for womens cancers, including cancers of the breast, uterus, ovaries, cervix, vagina and vulva.

Kawar, who was an undergraduate at the University of California in Los Angeles when studies were emerging on inherited risks for womens cancers and how they can overlap, now practices at Mercy Medical Centers recently opened Center for Breast Health and Gynecologic Oncology, formerly its Breast Health Center, under Dr. James Frank, and feels very lucky to have the one-stop location adjacent to the Sister Caritas Cancer Center for her patients who sometimes have overlapping cancers.

This vision of seeing everyone in the same building, sharing resources, imagining my career in a different way - I am very lucky to be here, said Kawar, noting that inherited mutations in certain genes can put a small percentage of the population at risk for breast cancer as well as ovarian cancer and cancer of the endometrium-uterus.

I have already seen lots of patients who have both cancers of the breast as well as gynecologic. Here, they can come to one space, see one doctor or other doctors and do not have to go to other locations.

She sees such an approach where a physician like herself provides comprehensive care for female cancers in one location as all about womens cancer care.

Kawar added patients at the center have access to a genetics counselor who can help determine cancer risk based on inherited factors and treatment options that range from surgery to reduce such risk to minimally invasive surgeries as well as radical procedures for those with malignancies.

She said that as medicine evolved over the last century that there was this sort of arbitrary separation of breast surgery into the field of general surgery where gynecologic oncology evolved within a subspecialty of gynecology and obstetrics.

There was this separation and finally care of breast cancers separate from gynecologic and pelvic cancers, Kawar said.

Breast cancers are mostly uniquely female, although some men get breast cancer, it is a very much a womans cancer.

The greater prevalence of breast cancer and the growing number of disease survivors, Kawar added, has helped generated much greater publicity and funding around it than cancers of the reproductive organs that are much less common though can be related.

Kawar said patients are most often referred to her by their gynecologist after an imaging study indicating a tumor or some other abnormality.

She said the most common gynecologic cancers she sees in patients are uterine cancer, which is often found early due to abnormal bleeding or pain and has a high five-year survival rate when detected in the localized state; ovarian cancer which she termed much more deadly as it is often detected when the disease is more advanced; and cervical cancer that is often caused by exposure to certain strains of the human papillomavirus and for which there is now a vaccine to help prevent.

Screening for cervical cancer can be done by the HPV or Pap test and the five-year survival rate is very high when detected at the localized stage.

Risk factors for uterine or endometrial cancer, Kawar said, include metabolic syndrome, whose conditions include high blood pressure, obesity and diabetes, but just how this syndrome contributes to the development of the cancer is unknown.

She said too much of the hormone estrogen without the presence of progesterone can also pose a risk.

Kawar said hereditary breast and ovarian cancer syndrome, often related to certain mutations in the BRCA1 or the BRCA2 gene, can elevate an individuals risk for both as well as other cancers.

She noted that there is no good screening test for ovarian cancer and one recommendation for women with a known inherited risk for the disease is risk-reducing surgery to remove the Fallopian tubes and ovaries after child bearing years.

She added, The symptoms of ovarian cancer are normally very vague - urinary symptoms like urgency or frequency, abdominal pain, feeling full quickly - these usually cause women to ultimately seek care and are often have their symptoms mistaken for stomach problems or indigestion and with a diagnosis of ovarian cancer quite late because of that.

Anyone with a strong family history of breast or ovarian cancers should seek genetic counseling and possibly genetic testing because that is one way to become aware of the risk for ovarian cancer, Kawar said.

Other risk factors include infertility - not being able to bear children - and age. It normally affects women age 60 and above.

Kawar said not all women referred to the center end up being treated for a malignant condition, but surgery is sometimes needed because of a concern for cancer.

When a woman is referred to me with a pelvic mass found on imaging, I will talk about the possibility of cancer with the goal of surgery to remove the mass and determine diagnosis and if it is cancer, to recommend the appropriate treatment which may include more extensive surgery or chemotherapy, Kawar said.

I often treat women for endometriosis which is a benign condition but can mimic cancer in the problems it causes and might require a large-scale surgical approach. I often see women for uterine bleeding that may end up being polyps and not necessarily cancer.

Kawar noted that this is Gynecological Cancer Awareness Month, and next month brings Breast Cancer Awareness Month.

September brings awareness of all the problems of the gynecologic cancers and the importance to survival of catching them early, Kawar said.

With a lot of emphasis on breast cancer in October.

The American Cancer Society estimates this year that 42,170 women will die of breast cancer, and some 33,602 will die of cancers of the genital system.

These include 13,940 of ovarian cancer, 12,590 of uterine cancer, 4,290 of cervical cancer, 1,350 of vulva cancer and 1,450 of vaginal and related cancers.

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Mercy Medicals new Center for Breast Health, Gynecologic Oncology is all about womens cancer care - masslive.com

Dublin, Sept. 04, 2020 (GLOBE NEWSWIRE) -- The "Japan In-Vitro Diagnostics (IVD) Market, by Diagnostics, Companies, Reimbursements, Porter's Model, Growth Drivers, Opportunities Challenges" report has been added to ResearchAndMarkets.com's offering.

According to the report, Japan's In-vitro Diagnostic Market is projected to reach US$ 4.43 billion by 2026.

As most of the industry growth rate in Japan is hit due to COVID-19, but on the contrary, Japan In-Vitro Diagnostics Market is expected to put an exceptional higher growth rate in 2020 compared to its past years (read the report for Coronavirus impact on IVD industry of Japan).

In-vitro Diagnostics falls under the medical devices segment, which is used by disposable & consumable, and it is also used in many different, different types of medical tones to find multiple bio-samples. In recent years, several developments have happened in the field of In-vitro diagnostics like conventional diagnostics to new generation gene diagnostics. This has become possible with the advent of new technologies, such as genetic testing, chain reaction (PCR), next-generation sequencing (NGS), and molecular diagnostics.

Factors driving the IVD Market in Japan

In Japan, a quarter of its population age 65 years & above and also has the highest proportion of the aging population across the globe. The main problem faced by the Japanese government in recent years is the rise in the number of an aging population, as the cases of aging diseases are multiplying. Accordingly, the Japanese government has given priority to deal with the aging population, and the government is expected to devote an expanded health budget to aging by 2025. This will boost the future of the Japanese In-Vitro Diagnostics Industry by rising prevalence and increased public expenditure.

Apart from that enhanced diagnostic technology, people's awareness and the subsequent growth in the prevalence of chronic and infectious diseases, a rise in the number of private hospitals, and independent testing laboratories are also some of the other factors that contribute to its market growth. Japan's clinical laboratory markets represent one of the largest and fastest-growing markets among the top ten IVD nation markets in the Asia Pacific regions.

This report provides a complete analysis of Japan In Vitro Diagnostics (IVD) Market.

All the 11 Segments analysis of Japan In-Vitro Diagnostics Market

In this report, we have provided a complete analysis of 11 segments of the Japan In-vitro Diagnostic market. These segments are as follows Clinical Chemistry, Urine & Feces, Hematology, Tumor Marker, Self Monitoring Blood Glucose (SMBG), Immunology, Infectious disease, Microbiology, Pathology, Genetic Testing, and Others. In these In vitro diagnostics segments, we have done a comprehensive analysis of each segment due to COVID-19 along with separate growth factors for each segment.

Good Reimbursement Policy is expected to further boost the Market

The report describes the scope and breadth of the reimbursement policies along with the full context. It also provides specific guidance and structure about how it operates and how Japanese authorities implement reimbursement policies. It describes how medical devices are categorized in Japan and which class In vitro diagnostic suits. It includes all medical manufacturers that have been in Japan for the past five years applying for reimbursement approval.

Key Topics Covered

1. Introduction

2. Research Methodology

3. Executive Summery

4. Market Dynamics 4.1 Growth Drivers4.2 Challenges4.3 Opportunities

5. Porter's Five Forces Analysis 5.1 Threat of New Entry5.2 The Bargaining Power of Buyer5.3 Threat of Substitution5.4 The Bargaining Power of Supplier5.5 Competitive Rivalry

6. Reimbursement Policy

7. Japan in Vitro Diagnostics Market

8. Market Share - Japan in Vitro Diagnostics 8.1 By Segment

9. Segments - Japan in Vitro Diagnostics Market 9.1 Urine & Faces Diagnostics9.2 Hematology9.3 Clinical Chemistry9.4 Self-Blood Glucose Monitoring9.5 Tumor Marker9.6 Immunology9.7 Infectious Testing9.8 Microbiology9.9 Pathology9.10 Genetic Testing9.11 Others

10. Company Analysis 10.1 Abbott Laboratories10.2 Danaher Corporation10.3 bioMerieux10.4 Roche Diagnostics10.5 Becton Dickonson

For more information about this report visit https://www.researchandmarkets.com/r/jbwr8d

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Japanese In-Vitro Diagnostics (IVD) Industry 2020-2026 with Analysis on Abbott Labs, Danaher, bioMerieux, Roche Diagnostics and BD - GlobeNewswire

Study on the Global Preimplantation Genetic Testing Market

The market study on the Preimplantation Genetic Testing market published by Fact.MR highlights the essential parameters that are expected to shape the growth of the Preimplantation Genetic Testing market in the upcoming years. The report maps the trajectory of the Preimplantation Genetic Testing market by taking into account historical data for the period between 20XX-20XX and considering 20XX-20XX as the forecast period.

The presented study evaluates the different factors that are likely to influence the dynamics of the Preimplantation Genetic Testing market including the current trends and recent developments on the technological front. In addition, the micro and macro-economic factors that are likely to impact the growth of the Preimplantation Genetic Testing market during the assessment period are assessed in detail.

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Segmentation of the Preimplantation Genetic Testing Market

The analysts have segmented the Preimplantation Genetic Testing market into various sections to offer a microscopic understanding of the market. The different segments studied in the report include:

Competition Tracking

The report also profiles companies operating in the preimplantation genetic testing market, which include Agilent Technologies Inc., Abbott Laboratories, CooperSurgical Inc., Oxford Gene Technology IP, Illumina, Inc., Thermo Fisher Scientific, Inc., PerkinElmer, Inc., Genea Limited, Natera, Inc., Rubicon Genomics, Inc., and CombiMatrix Corporation.

Note: The insights mentioned here are of the respective analysts, and do not reflect the position of Fact.MR

Critical insights enclosed in the report:

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The report aims to provide answers to the following questions related to the Preimplantation Genetic Testing market:

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Preimplantation Genetic Testing Market Industry Production and Demand, Competition News and Trends Forecasts to 2017 to 2022 - Scientect

CLAIM

Birthmarks are indicators of the MTHFR gene; When people have MTHFR their chances of vaccine reactions increase because they cannot detox the toxins from the vaccines

DETAILS

Incorrect: Birthmarks are not indicators of mutations in a gene that codes for an enzyme called methylenetetrahydrofolate reductase (MTHFR gene) or any other genetic condition. Mutations in this gene, involved in vitamin B9 production, are also not associated with a higher risk of adverse effects of vaccines. Some rare mutations in the MTHFR gene lead to a metabolic disorder, but most of the common MTHFR mutations have little or no impact on human health.Misrepresents source: The claim misrepresents findings from a single study to incorrectly associate mutations in the MTHFR gene with adverse effects from vaccination. The authors of the study denounced the inappropriate use of their article to support medical exemptions to vaccination in children who have variations in the MTHFR gene.

KEY TAKE AWAY

Every person has a gene that produces an enzyme called methylenetetrahydrofolate reductase (MTHFR gene), which converts folic acid into its active form folate, also called vitamin B9. This gene helps repair DNA and remove free radicals. People with some rare mutations in the gene may have an increased risk of developing skeletal and neurological problems or blood clots, due to a reduction in MTHFR enzyme activity. However, most of the common MTHFR mutations either do not affect enzyme activity or only require individuals with the mutation to supplement their diets with folic acid. No scientific evidence supports the claim that mutations in the MTHFR gene are associated with either birthmarks or a higher risk of adverse reactions to vaccines.

REVIEW A Facebook post from mid-November 2018 went viral in late August 2020, receiving tens of thousands of interactions on Facebook. The post incorrectly claims that birthmarks are indicators of the presence of the methylenetetrahydrofolate reductase (MTHFR) gene, involved in the production of vitamin B9, and that the gene is associated with a higher risk of adverse reactions to vaccines. Because the MTHFR gene is present in every person, the author of the post is likely referring to mutations in the gene, rather than the gene itself. While some rare MTHFR mutations are the cause of a metabolic disorder, most of the mutations in this gene are very common among the population and do not represent a health risk. As we explain below, there is no scientific evidence that mutations in the MTHFR gene are associated with the presence of birthmarks or a higher risk of adverse reactions to vaccines.

The MTHFR gene produces an enzyme that converts folic acid, which occurs naturally in food, to its active form folate, also called vitamin B9. Folate is essential for DNA repair, eliminating free radicals, and methylation, a process that helps regulate protein production. Specifically, folate converts the amino acid homocysteine into other amino acids involved in methylation and in the production of the antioxidant glutathione[1]. Folate deficiencies can lead to the toxic accumulation of homocysteine in the blood (hyperhomocysteinemia), which may increase the risk of spina bifida, a birth defect in which the spine and spinal cord do not form properly, as well as blood clotting and a variety of skeletal and neurological problems[2].

People who have rare mutations in the MTHFR gene can experience increased homocysteine levels in their blood due to reduced MTHFR enzyme activity. However, for people with other common MTHFR gene mutations, homocysteine levels in their blood are either unaffected or only increased when they have a dietary deficiency in folic acid[3]. Contrary to the posts claim, genetic testing has minimal clinical utility, and the diagnosis of hyperhomocysteinemia relies on a blood test that measures total levels of homocysteine[4]. However, genetic testing may be used to confirm the diagnosis of an inherited hyperhomocysteinemia caused by MTHFR deficiency.

Also contrary to the claim, there is no scientific evidence that birthmarks, such as stork bites, sugar bugs, and sacral dimples, are indicators of mutations in the MTHFR gene. These skin marks result from the overgrowth of blood vessels or pigment cells, but the cause of such overgrowth is unknown. In general, birthmarks are harmless and fade over time without requiring treatment. However, experts recommend monitoring birthmarks that are large, located along the spine, or interfere with normal activity.

There is also no scientific evidence to support the claim that mutations in the MTHFR gene increase a persons risk of adverse reactions to vaccines. This claim is likely based on a single study published in 2008 in the Journal of Infectious Diseases exploring whether one mutation in the MTHFR gene increased the risk of adverse effects to an experimental vaccine against smallpox. While the study authors observed local inflammation at the site of injection, fever, rashes, and lymph node swelling in 24 out of 46 participants, they did not report any severe or long-term effects[5]. The authors also wrote a 2019 letter clarifying that their research should not be used as evidence for an association between the MTHFR gene and an increase in adverse reactions to vaccines after several people misinterpreted their results[6]. The letter states, [t]he study was a small, underpowered, exploratory, candidate gene study conducted [more than] 15 years ago in a special populationparticipants in 2 small phase 1 studies of smallpox vaccines. This article does not meet the standards for establishing a robust genetic association.

The authors also pointed out that their study involved an experimental vaccine that was in clinical trial and not approved by the U.S Food and Drug Administration (FDA). In addition, the vaccine was for smallpox, which was eradicated in 1980. Calling attention to the inappropriate use of their study to justify vaccine exemptions, the researchers stated in their letter that:

The citation of this exploratory report, which addressed a unique set of phase 1 studies of a candidate smallpox vaccine, should not constitute an exemption from formal vaccination recommendations issued by the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices. [] It is unfortunate that the loose application of our exploratory report has been misinterpreted and used to inappropriately justify exemption of children from medically indicated vaccines.

In summary, there is no scientific evidence to support the claim that mutations in the MTHFR gene are associated with birthmarks or a higher risk of adverse events from vaccines. While some people with rare mutations of the MTHFR gene have an increased risk of blood clot formation and skeletal or neurological problems, most mutations do not affect a persons health.

Originally posted here:
A person's response to vaccination is not associated with birthmarks or the presence of mutations in a gene involved with vitamin B9 production -...

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Predictive Genetic Testing 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 Predictive Genetic Testing market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Predictive Genetic Testing market to assist our clients arrive at beneficial business decisions.

The recent published research report sheds light on critical aspects of the global Predictive Genetic Testing market such as vendor landscape, competitive strategies, market drivers and challenges along with the regional analysis. The report helps the readers to draw a suitable conclusion and clearly understand the current and future scenario and trends of global Predictive Genetic Testing market. The research study comes out as a compilation of useful guidelines for players to understand and define their strategies more efficiently in order to keep themselves ahead of their competitors. The report profiles leading companies of the global Predictive Genetic Testing market along with the emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.

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The recent published study includes information on key segmentation of the global Predictive Genetic Testing market on the basis of type/product, application and geography (country/region). Each of the segments included in the report is studies in relations to different factors such as market size, market share, value, growth rate and other quantitate information.

The competitive analysis included in the global Predictive Genetic Testing market study allows their readers to understand the difference between players and how they are operating amounts themselves on global scale. The research study gives a deep insight on the current and future trends of the market along with the opportunities for the new players who are in process of entering global Predictive Genetic Testing market. Market dynamic analysis such as market drivers, market restraints are explained thoroughly in the most detailed and easiest possible manner. The companies can also find several recommendations improve their business on the global scale.

The readers of the Predictive Genetic Testing Market report can also extract several key insights such as market size of varies products and application along with their market share and growth rate. The report also includes information for next five years as forested data and past five years as historical data and the market share of the several key information.

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Global Predictive Genetic Testing Market by Companies:

The company profile section of the report offers great insights such as market revenue and market share of global Predictive Genetic Testing market. Key companies listed in the report are:

key players in the predictive genetic testing market. The significant competitive strength of the existing players in the evolving landscape of the global predictive genetic testing market is anticipated to offer new prospect in widening the application of the predictive genetic testing, substantially driving predictive genetic testing market growth. The key manufacturers of the predictive genetic testing are greatly concentrated on the technical edification of the end users to improve consumer outcomes. Furthermore, the adoptions of advanced predictive genetic testing services is expected to create lucrative growth opportunities for the service and third-party market competitors. Growing inclination toward trend in predict is prevention is estimated to offer growth opportunity for Predictive genetic testing market. Selection of treatment regimen with Predictive genetic testing is projected to aid capturing higher share in Predictive genetic testing market.

Geographically, global Predictive genetic testing market is segmented into seven key regions viz. North America, Latin America, Europe, South Asia, East Asia Oceania and Middle East & Africa. North America is prominent region in Predictive genetic testing Market. Advancement in genetic care facilities, higher adoption to lifestyle changes, increase awareness about genetic disease, increase in preventative care and favorable government policies have improved the regulatory scenario for predictive genetic testing devices in north America. Additionally in Asia pacific region considerably higher market growth rate is expected due to constantly rising population and higher incidence of genetic abnormality. Relatively affecting the Predictive genetic testing market.

Some of the major key players competing in the global Predictive genetic testing Market are Myriad Genetics, Inc., Abbott Laboratories, Illumina, Inc., Genesis GeneticsThermo Fisher Scientific, Inc., Bio-Rad Laboratories Inc., , Agilent Technologies, F. Hoffmann-La Roche Ltd., Counsyl, Inc., ARUP Laboratories. BGI among others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

Global Predictive Genetic Testing Market by Geography:

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Some of the Major Highlights of TOC covers in Predictive Genetic Testing Market Report:

Chapter 1: Methodology & Scope of Predictive Genetic Testing Market

Chapter 2: Executive Summary of Predictive Genetic Testing Market

Chapter 3: Predictive Genetic Testing Industry Insights

Chapter 4: Predictive Genetic Testing Market, By Region

Chapter 5: Company Profile

And Continue

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Lucrative Opportunities in North America to Propel the Growth of the Predictive Genetic Testing Market 2019 2029 - The Daily Chronicle

Transparency Market Research (TMR) has published a new report titled, Genetic Testing Services Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027.According to the report, the global Genetic Testing Services market was valued at US$ 41.2 Bn in 2018 and is projected to expand at a CAGR of 7.3% from 2019 to 2027.

Overview

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New Born Screening Segment to Dominate Global Genetic Testing Services Market

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Oncology Segment Hold a Major Share of Global Genetic Testing Services Market

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Hospitals based laboratories Segment to Dominate Global Genetic Testing Services Market

North America to Dominate Global Genetic Testing Services Market

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Competitive Landscape

The global genetic testing services market is consolidated in terms of number of players. Key players in the global Genetic Testing Services market include Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Genomic Health, Inc., NeoGenomics Laboratories, Inc, Eurofins Scientific, Ambry Genetics, Illumina, Inc, 23andMe, Inc., Exact Sciences, Natera, Invitae, Veracyte, and other prominent players.

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Genetic Testing Services Market: Surge in Adoption of Genetic Testing Services to Boost the Market - BioSpace

This article is the secondof a three-part conversation onBRCA1 and BRCA2 gene mutations. Read the first onehere.

BRCA1 and BRCA2 gene mutations are linked to the development of breast cancer, ovarian cancer and other types of cancer.

Genetic testing and counseling services can determine whether a person carries these mutations and, if they do, how the information could help inform cancer prevention or treatment decisions.

In the second of a three-part conversation, Kara Milliron, a genetic counselor at the University of Michigan Rogel Cancer Center's Breast and Ovarian Cancer Risk Evaluation Clinic, discusses different ways genetic testing can be useful.

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Milliron notes that genetic testing can provide useful information to people who have already been diagnosed with cancer as well as to those who are currently healthy.

Genetic testing can be useful not only to inform the family about potential cancer risks, but it also can drive treatment decisions, she says. And I think that this is a really important point because so many times when individuals are diagnosed with cancer, the first thing that they say to me is, Well, it's a moot point. I already have cancer, why would I undergo genetic testing? The guidelines for offering BRCA1 and BRCA2 testing are for any individual who has a metastatic cancer that falls on the BRCA1 and BRCA2 spectrum.

That would include women and men diagnosed with metastatic breast cancer; women with pelvic cancers including cancer of the ovaries, fallopian tubes or peritoneum; and men and women with metastatic prostate or pancreatic cancer.

And the reason behind that, is that BRCA1- and BRCA2-related cancers tend to respond to medications called PARP inhibitors, Milliron says. So, the information we learn from genetic testing can potentially help identify drugs that their cancer is more likely to respond to.

Additionally, she says, if a patients cancer hasnt spread and become metastatic, testing may still help doctors tailor a cancer screening plan for the patient.

Also, if we test someone who has a cancer diagnosis and we find a mutation in a gene, we can then test other family members specifically for that gene mutation and we can say very conclusively yes or no, who is at risk, Milliron adds. So, that's another reason to start with someone who has a cancer diagnosis because if we find something, we can then do what we call cascade testing, which is test to see if other family members carry that specific gene mutation.

Identifying family members who dont carry a mutation is as important and finding those who do, she says.

We can identify the people who are not at increased risk and we can save them from all of that additional screening, and so that is also a big public health win and helps reduce health care spending, Milliron says.

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BRCA1 and BRCA2 Gene Mutations: I Know I Have Cancer, What Good is Testing? - University of Michigan Health System News

The Genetic Testing Market report 2020 provides comprehensive analysis of Genetic Testing industry by types, applications, regions. It shows Genetic Testing market 2020-2024 by production, consumption, supply, gross margin, revenue of key players in the industry. Additionally, Genetic Testing market report covers market size, share, and growth rate of industry with respect to regions.

Genetic Testing market includes following leading manufacturers on the basis of sales, revenue, price, and gross margin.

Genetic Testing market report presents in-depth analysis regarding the development, current trends, industry policies, and regulations implemented in each of the geographical regions. It includes analysis of upstream raw materials, downstream demand, and current market dynamics. Furthermore, the Genetic Testing market report provides an in-depth insight into Genetic Testing industry during 2020-2024.

Scope of the Report:

This report includes an in-depth study of the genetic testing market. A genetic test is a test performed to identify the presence of a particular gene/s with a particular sequence of the genome. The gene/s can be identified either directly through sequencing or indirectly through various methods. Genetic testing practices are rapidly increasing in rare disease diagnostics and for personalized medicines, which in turn, is fueling the growth of this market.<

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Key Market Trends:

Molecular Testing Segment is Expected to Exhibit Fastest Growth Rate over the Forecast Period

Molecular genetic testing is the study of single genes or short lengths of DNA, to identify the mutations that lead to a genetic disorder. Molecular genetic testing can be used to diagnose many of the genetic disorders, but this type of technology may not be appropriate for diagnosis of all the genetic conditions. For example, molecular genetic testing is available for diseases, such as cystic fibrosis, sickle cell anemia, and Tay-Sachs disease. The initial diagnosis of these disorders usually is established by other methods. Therefore, molecular genetic testing is subject to limitations that must be recognized when ordering such testing.

The molecular testing market is growing at a good pace. Currently, most of the molecular tests involve either PCR or FISH. In addition, the microarray technology has made it possible to evaluate thousands of loci, which is extensively used for expression analysis, targeted to specific cell signaling pathways, and for metabolic pathways for pathological characterization of tumors as well. The advent of next-generation sequencing has also expanded the market studied in various fields, as it has brought a major increase in throughput capacity through automation, which ultimately leads to faster turnaround time and reduction in costs.

North America Captured the Largest Market Share and is Expected to Retain its Dominance

North America currently dominates the market for genetic testing, owing to factors, such as increasing demand for personalized genetic testing services in the region and rise in the prevalence of chronic disorders and genetic disorders. In the United States, two federal agencies have the primary authority to regulate genetic tests: the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). In the past, the Federal Trade Commission (FTC) has also played a role in regulating genetic testing companies who advertised false and misleading claims about their products, but this agency currently plays a more minor role in this space.

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Genetic Testing Market Report Covers the Following Questions:

Detailed TOC of Genetic Testing Market 2020-2024:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Emphasis on Early Disease Detection and Prevention4.2.2 Growing Demand for Personalized Medicine4.2.3 Increasing Application of Genetic Testing in Oncology4.3 Market Restraints4.3.1 High Costs of Genetic Testing4.3.2 Social and Ethical Implications of Genetic Testing4.4 Industry Attractiveness Porters Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 By Type5.1.1 Carrier Testing5.1.2 Diagnostic Testing5.1.3 Newborn Screening5.1.4 Predictive and Presymptomatic Testing5.1.5 Prenatal Testing5.1.6 Other Types5.2 By Disease5.2.1 Alzheimers Disease5.2.2 Cancer5.2.3 Cystic Fibrosis5.2.4 Sickle Cell Anemia5.2.5 Duchenne Muscular Dystrophy5.2.6 Thalassemia5.2.7 Huntingtons Disease5.2.8 Rare Diseases5.2.9 Other Diseases5.3 By Technology5.3.1 Cytogenetic Testing5.3.2 Biochemical Testing5.3.3 Molecular Testing5.4 Geography5.4.1 North America5.4.1.1 US5.4.1.2 Canada5.4.1.3 Mexico5.4.2 Europe5.4.2.1 Germany5.4.2.2 UK5.4.2.3 France5.4.2.4 Italy5.4.2.5 Spain5.4.2.6 Rest of Europe5.4.3 Asia-Pacific5.4.3.1 China5.4.3.2 Japan5.4.3.3 India5.4.3.4 Australia5.4.3.5 South Korea5.4.3.6 Rest of Asia-Pacific5.4.4 Middle East & Africa5.4.4.1 GCC5.4.4.2 South Africa5.4.4.3 Rest of Middle East & Africa5.4.5 South America5.4.5.1 Brazil5.4.5.2 Argentina5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Abbott Laboratories Inc.6.1.2 Bio-Rad Laboratories6.1.3 Danaher Corporation (Cepheid)6.1.4 F. Hoffmann-La Roche Ltd6.1.5 Illumina Inc.6.1.6 23andMe6.1.7 Eurofins Scientific SE (Eurofins)6.1.8 Genesis Healthcare6.1.9 Luminex Corporation6.1.10 Myriad Genetics Inc.6.1.11 Precipio (Transgenomics Inc.)6.1.12 Qiagen6.1.13 Thermo Fisher Scientific Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Genetic Testing Market: 2020 Global Challenges and Opportunities, Industry Size, Growth Rate, and Supply-Demand Analysis Forecast to 2024 Industry...

DETROIT, Sept. 1, 2020 /PRNewswire-PRWeb/ --Breast and ovarian cancers are common diseases that affect many women. According to the Centers of Disease Control (CDC), About 3% of breast cancers (about 7,500 women per year) and 10% of ovarian cancers (about 2,000 women per year) result from inherited mutations in the BRCA1 and BRCA2 genes. Both genes are detectable in the Women's Excellence Genetic Testing Program.

Dr. Jonathan Zaidan, MD, FACOG, President of Women's Excellence recommends genetic testing for all women, especially women with family members who have been diagnosed with breast or ovarian cancer. "Knowing your family cancer history and genetic make-up may help prevent cancer or detect it at an earlier stage," says Zaidan. "If your family has a strong history of ovarian or breast cancer, it is likely that you could carry the BRCA1 or BRCA2 gene mutation."

To be eligible for genetic testing, patients need to identify their hereditary cancer risk. Women's Excellence offers a quick risk assessment survey at https://www.womensexcellence.com/risk-assessment/. Once the assessment has been completed, Women's Excellence will contact you within 72 hours to schedule your genetic test or an overall cancer prevention visit within.

To schedule an in-office appointment or a telemedicine consultation, visit http://www.WomensExcellence.com. Online Patient Support Specialists are available Monday through Friday from 8am-5pm to assist new, current, and prospective patients. The chat is located at the bottom right corner of your computer or mobile device screen at http://www.WomensExcellence.com. During offline hours, all chats sent will be messaged directly to a Women's Excellence team member. Offline messages will receive a response within 24 hours. Messages received during the weekend will be answered the next business week. Appointments can also be made at (248) 693-0543.

About Women's Excellence Women's Excellence is the most comprehensive obstetric and gynecologic office in Michigan. Additionally, they specialize in menopause, weight control, bladder control, endometriosis, robotic surgery, oncology, and midwifery services. Women's Excellence is committed to staying at the forefront of innovation with cutting edge technologies utilizing robotic surgery and minimally invasive surgical options when possible. The knowledgeable, compassionate physicians and healthcare providers of Women's Excellence focus on patient-centered processes to deliver the highest quality of care. They are affiliated with most insurances. They offer seamless medical record access via a state-of-the-art patient portal and use the latest technology for record keeping and sharing, making the patient experience easier and more efficient. Women's Excellence is taking new patients and is conveniently located throughout southeastern Michigan in Clarkston, Lake Orion, Lapeer, Rochester, Royal Oak, and West Bloomfield. Women's Excellence is also a proud partner of Detroit's longstanding radio network, WJR 760AM, providing expert women's health news and information. For more information, visit http://www.WomensExcellence.com.

SOURCE Women's Excellence in Obstetrics and Gynecology

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Women's Excellence Offers In-Office Genetic Testing and Evaluation of BRCA1 and BRCA2 Genes for Breast and Ovarian Cancers - Benzinga

A recently published insights research report by Fact.MR on the Preimplantation Genetic Testing Insights depicts a crystal clear view of the insights over the considered period of assessment (2017 2022). The global preimplantation genetic testing insights study comes with an all in all compilation of the future, existing, and historical outlook of the insights as well as the factors bringing in such growth for the insights. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities, and threats of each preimplantation genetic testing insights player in a comprehensive way. Further, the preimplantation genetic testing insights report emphasizes the adoption pattern of the preimplantation genetic testing across various industries.

The existing trends, restraints, opportunities, and insights drivers are studied thoroughly to offer a clear, 360-degree understanding of the existing landscape prevailing in the preimplantation genetic testing insights. The research paints a detailed picture of how the insights is likely to take shape in the coming years given the influence of current drivers, opportunities, and restraints. In this latest insights research study published by Fact.MR, the analysts have taken into account the preimplantation genetic testing insights from a local as well as global viewpoint.

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The outbreak of novel coronavirus across the globe has changed the way about how we do business, it has resulted in both disadvantages and advantages for players operating in the preimplantation genetic testing insights. A health crisis of enormous proportion, COVID-19 has emerged as a pandemic that would cause a restructuring of the world economy as well as social order. This outbreak is clearly going to characterize the coming era with fundamental schism. Many companies have shifted from their traditional methods of advertising during the lockdown period.

Taking help of this latest offering on the preimplantation genetic testing insights by Fact.MR, the insights players, suppliers, distributors, and other stakeholders can formulate innovative strategies based on their understanding of the pandemic and our report to expand their business and widen their base of customers. This research study by Fact.MR is likely to detail the factors that could impact the sales of products/ services in the global insights landscape. The report is also likely to suggest avenues of growth that could boost sales in the post-pandemic era.

According to the insights research report, the preimplantation genetic testing insights is estimated to register a CAGR growth of 8.4% over the assessment period due to several key factors that is likely to influence the insights, such as favorable regulatory policies, augmented spending on research and development. The analysts at Fact.MR makes use of the latest research methodologies while gathering data from credible and reliable sources, both primary and secondary, to prepare and present the insights study.

In this preimplantation genetic testing insights study, the following years are considered to project the insights footprint:

The preimplantation genetic testing insights report has answers to important questions, which include the following:

The preimplantation genetic testing insights report covers the following regions:

On the basis of product type, the preimplantation genetic testing insights report considers the following segments:

On the basis of end-use, the preimplantation genetic testing insights report includes:

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The behavioral pattern of each of the insights player, such as acquisitions, new product launches, partnerships, and mergers have been thoroughly studied to offer a detailed view of the competitive landscape of the preimplantation genetic testing insights.

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Preimplantation Genetic Testing Insights Size to Expand Lucratively during the Forecast Period 2017-2022 - The Cloud Tribune

Global Europe Genetic Testing Market report is an overview of the global market is provided with prime focus on factors boosting and hampering market. This will help investors get a clear understanding on which aspects to focus on and how to economically support the market globally. The impact of prevailing regulatory scenario on both regional and worldwide Europe Genetic Testing market is provided detail in this report.

Market Dynamics:

The report provides key statistics on the market status of the Europe Genetic Testing Market manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the Europe Genetic Testing.

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Key questions answered in the report include:

Key Market Trends:

Diagnostic testing is the segment under type of testing that is expected to grow fastest during the forecast period

Predictive and presymptomatic testing dominated the European genetic testing market system, as it is utilized for the detection of gene mutations related to disorders that appear after birth, frequently in later stages of life. Such tests can be of assistance to individuals having a family member with a genetic disorder, though they are free of any features of the disorder while testing.

Diagnostics testing is expected to register a CAGR of 14.29%, as it is used to diagnose or rule out a specific genetic condition. In most cases, genetic testing is used to confirm a diagnosis when a particular condition is suspected based on physical mutations and symptoms. Furthermore, companies, such as Centogene and NIMGenetics, offer a wide range of genetic diagnostic services in Europe, which is further accelerating the growth of the market.

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Study objectives of Europe Genetic Testing Market Report:

Detailed TOC of Europe Genetic Testing Market Report 2019-2024:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Emphasis on Early Disease Detection and Prevention4.2.2 Increasing Demand for Personalized Medicine4.2.3 Increasing Application of Genetic Testing in Oncology4.3 Market Restraints4.3.1 High Costs of Genetic Testing4.3.2 Social and Ethical Implications of Genetic Testing4.4 Porters Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 Type5.1.1 Carrier Testing5.1.2 Diagnostic Testing5.1.3 Newborn Screening5.1.4 Predictive and Presymptomatic Testing5.1.5 Prenatal Testing5.1.6 Nutrigenomic Testing5.2 Disease5.2.1 Alzheimers Disease5.2.2 Cancer5.2.3 Cystic Fibrosis5.2.4 Sickle Cell Anemia5.2.5 Duchenne Muscular Dystrophy5.2.6 Thalassemia5.2.7 Huntingtons Disease5.2.8 Special Disease5.2.9 Other Diseases5.3 Technology5.3.1 Cytogenetic Testing5.3.2 Biochemical Testing5.3.3 Molecular Testing5.4 Geography5.4.1 Europe5.4.1.1 Germany5.4.1.2 United Kingdom5.4.1.3 France5.4.1.4 Italy5.4.1.5 Spain5.4.1.6 Rest of Europe

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Illumina Inc.6.1.2 Abbott Laboratories6.1.3 23andMe Inc.6.1.4 F. Hoffmann-La Roche Ltd6.1.5 Qiagen6.1.6 Blueprint Genetics Oy6.1.7 Eurofins Scientific6.1.8 Centogene AG6.1.9 Thermo Fisher Scientific6.1.10 Elitech Group

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Global Genetic Testing Market Anticipates Growing With a Rapid Growth Rate during the Forecast Period: Market Research Store

Market Research Storehas published a new report on the globalGenetic Testing marketwhich deals with the market scenario amid COVID-19 situation.According to the research conducted by our research analysts the global Genetic Testing market demand was USD XX Million in 2019 and it is anticipated that by the end of 2026 the market will gain USD XX Million. The anticipated growth rate for the market is XX% during the forecast period 2020 to 2026. The basic data that are included in the report are the market share and size, growth drivers, limitations, trends and challenges, and the industry players that are involved in the business.

Click Here To Access The Free Sample PDF Report (including COVID-19 Impact Analysis, full TOC, Tables and Figures):www.marketresearchstore.com/report/global-genetic-testing-industry-market-report-2019-industry-697208#RequestSample

The global Genetic Testing market has been segmented into{Newborn screening, Diagnostic testing, Carrier testing, Preimplantation genetic diagnosis, Prenatal diagnosis, Predictive and presymptomatic testing, Pharmacogenomics}; {Cystic fibrosis, Sickle cell anemia, Duchenne muscular dystrophy, Alzheimer disease, Thalassemia, Huntington disease, Others}. Deep analysis of the segment and its type is conducted by our research analysts and has passed the information in the report in the form of tables and figures for better and easy understanding of the clients. Our research team has not limited their data with the current market scenario but has studied the market conditions from the past and has forecasted the future market conditions. Regional analysis of each segments of the market has also been included in the report. Even though the primary focus of the market was in five major regions North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa country-wise data is also available within the report.

The global Genetic Testing market report covers the following areas:

Genetic Testing market sizing Genetic Testing market forecast Genetic Testing market industry analysis

Focus has been given on robust vendor analysis so that the clients can improvise their decision-making skills in order to gain a noteworthy market position on the global platform. The major industry players that are mentioned in the report includeUnited Gene, Berry Genomics, SinoGenoMax, 360Jiyin, Novogene, Gene Kang, GenePlanet, BGI, Aijiyin, Geeppine, Asper Biotech, 23andMe, Inc, Courtagen Life Sciences, CapitalBio, Pathway Genomics, Agen, Gene by Gene, Repconex, Find Bio-Tech, Annoroad, Biomarker, GeneTests, Aiyin Gene, HI Gene, Counsyl, Inc., GeneDx, Natera, Inc, Biomedlab, Regulatory. Along with this all the manufacturers, suppliers, and distributors that are operating in the global Genetic Testing market have been profiled in the report.

Read Detailed Index of full Research Study at@www.marketresearchstore.com/report/global-genetic-testing-industry-market-report-2019-industry-697208

The major points that are covered:

Overview: In this section, definition of the global Genetic Testing Market is given along with the overview of the report in order to give a board outlook about the nature and contents of the research study.

Industry Players Strategies Analysis: The market players will be benefitted from this analysis as it will help to gain competitive advantage over their competitors.

Key Market Trends: In this section, in-depth analysis of the markets latest and future trends is discussed.

Market Forecasts: The research analysts have provided accurate and validated values of the total market size in terms of value and volume. Other offerings in the report include consumption, production, sales, and other forecasts for the global Genetic Testing Market.

Regional Analysis: Major five regions and its countries have been covered in the global Genetic Testing market report. With the help of this analysis, market players will have estimates about the untapped regional markets and other benefits.

Segment Analysis: Accurate and reliable forecasts about the market share of the important segments of the Genetic Testing market is provided.

Inquire more or share questions if any before the purchase on this report::www.marketresearchstore.com/report/global-genetic-testing-industry-market-report-2019-industry-697208#InquiryForBuying

Key Questions Answered in the Report Include:

What will the market size and the growth rate be in 2026? What are the key factors driving the global Genetic Testing Market? What are the key market trends impacting the growth of the global Genetic Testing Market? What are the challenges to market growth? Who are the key vendors in the global Genetic Testing Market? What are the market opportunities and challenges faced by the vendors in the global Genetic Testing Market? What are the key outcomes of the five forces analysis of the global Genetic Testing Market?

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What Will Be The Value Of The Global Genetic Testing Market 2020 During The Coronavirus (COVID 19) Period? - Northwest Trail