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NEW YORK — Europe's new In Vitro Diagnostic Regulation (IVDR) is not only remaking the way that manufacturers obtain regulatory compliance for their test kits, it may also reshape the way that laboratories use in-house assays for diagnostics. Stipulations in the new regulation, which began to apply last month, call for labs to either adopt tests and platforms that hold a CE-IVDR mark, or to justify to local authorities their reasons for using an in-house assay instead. That factor plus others could cause more labs to switch to commercial platforms, according to Anna Sadio, manager of regulatory affairs for Europe, the Middle East, and Asia at Thermo Fisher Scientific. "With the use of in-house and research-use-only assays, severely limited labs will be strongly pushed to use CE-IVD marked devices," Sadio said during a company satellite presentation at the European Society of Human Genetics meeting held in Vienna and virtually this week. Such a shift away from in-house devices, also called laboratory-developed tests or homebrews, could have a far-reaching impact on the European diagnostics market, Sadio noted. While a 2021 BioMed Alliance survey found that roughly half of the tests run by European labs today are in-house assays (IHAs), Sadio noted that the majority of genetic tests are developed in house, while labs tend to buy and use commercial, CE-IVD marked blood tests or clinical chemistry assays. Most genetic tests, Sadio said, were self-certified under 1998's In Vitro Diagnostic Directive, which remained in force until this year. They now fall under Class C of the IVDR, meaning they will require review by a notified body and certification. In January, European regulators agreed to extend timelines for certain classes of products that already hold CE-IVD marks under the IVDD. That means that Class C devices that already held a CE-IVD mark prior to the May 26, 2022, date of application of the IVDR, do not need to obtain a new certificate under the IVDR until May 2027. However, Sadio said, all of Thermo Fisher Scientific's assays are paired with instruments, which are considered to be Class A devices, and already need to meet IVDR guidelines, albeit via a self-certification process. Thermo Fisher Scientific announced earlier this month that its Applied Biosystems QuantStudio 5 Dx Real-Time PCR System already is compliant with the IVDR. She added that the system retains a separate assay development mode, so that users can develop in-house assays focused on rare conditions and diseases for which commercial kits do not yet exist. It appears Thermo Fisher will likely seek CE-IVDR certificates for other instrument platforms. In a Q&A session following Sadio's talk, Alan Livingston, Thermo Fisher Scientific's regional managing director, commented that "many of [the company's] instruments are going through the certification process," and confirmed, when asked, that its high-throughput GeneTitan Multi-Channel Instrument would be one such product. During her talk, Sadio walked through the timelines around the IVDR that most affect European labs. She said that European labs are already expected to be compliant with the general safety requirements of the IVDR. By May 2024, they must also show they have appropriate quality management systems in place, such as the ISO 15189 standard, as well as manufacturing process accreditations. By May 2028, they must also be able to justify to local authorities their use of in-house assays over commercially available tests. While that deadline is six years off, Sadio said that labs need to develop their IVDR strategies by assessing inventories and deciding on what to do if commercial kits do exist. This might include making decisions about what instruments to invest in, in order to move to a commercial system. "Labs need to think about complying with the first wave of requirements now," said Sadio. "Do a gap analysis, don't reinvent the wheel, have a look at the processes and documentation you already have, and try to adapt," she said. She reiterated that the market may see a decreased demand for RUO products and increased demand for CE-IVDR marked products because of this part of the regulation. Those who opt to stick with their in-house assays "have to be ready to defend this," said Sadio. As other observers have noted , the implementation of the IVDR has been challenging. A lack of capacity within designated notified bodies to handle the volume of submissions, compounded by the pressure the COVID-19 pandemic put on regulators, manufacturers, and labs alike, led to the extended transition periods announced in January, and continue to present issues in the segment. Sadio noted that clinical labs have not had time to prepare for the IVDR because of the pandemic, while infrastructure and guidelines in Europe are still being built to support the regulation. She said, for instance, that specifications covering Class D devices have not yet been published. The IVDR also calls for the establishment of EU reference labs to ensure the compliance of IVDs with the regulation. Sadio said that such labs have not yet been designated. For its part, Thermo Fisher offers a variety of material on its website for those transitioning to the IVDR. The regulatory compliance of a product may indeed be increasingly weighing on users. During the workshop, Miguel Milán, director of prenatal genetic diagnostics at Igenomix, a medical testing laboratory based in Valencia, Spain, said that when his lab was looking to adopt a platform for chromosomal microarray analysis last year, most offerings on the market were for research use only. He said that Igenomix opted to acquire Thermo Fisher Scientific's GeneChip System 3000Dx, which already carries a CE-IVD mark, because it was compliant with the IVDD. According to Milán, Igenomix runs the company's CytoScan Dx Assay Kit on the system, but because the system can also support research-use-only assays, it can be used for in-house tests. He said there are still conditions and diseases for which Igenomix needs to develop its own assays, a "costly and time-consuming" process. Being able to run both on the same system was seen as a reason to invest in the platform. "We can run all the experiments we want on the same instrument," he said. "This was important for us."

At ESHG, Thermo Fisher Official Predicts IVDR Will Push Labs to Replace LDTs With Commercial Kits

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TAMPA, Fla., June 7, 2022 /PRNewswire/ -- Pinnacle Fertility (Pinnacle), the fastest-growing network of physician-centered fertility practices representing more than seven clinics and 20 locations nationwide, has partnered with Igenomix as their exclusive preimplantation genetics testing (PGT) laboratory and provider for genetic counseling services. Continuing Pinnacle's commitment to collaborative medical leadership and patient-first care, this strategic partnership was the result of the Medical Council's collective determination and offers patients an increased opportunity to find success in their family-building journey. "Our Medical Director Council extensively studied the science behind major genetic labs to determine which would provide us with the best possible data to make key decisions. Bringing Igenomix on as our exclusive genetics provider for Pinnacle Fertility clinics continues to ensure that we meet our single guiding principle which is to provide the best patient outcomes possible," shares Dr. Richard Marrs, Chief Medical Director for Pinnacle Fertility. With more than 15 years of experience, Igenomix is the global leader in reproductive genetics and focuses on quality, safety, and science to help healthcare professionals and patients detect genetic abnormalities before treatment, avoid implantation failure, and ensure patients achieve a healthy pregnancy. "Pinnacle Fertility continues to set the standard in fertility care by bringing leading technology, integration and innovation to its suite of family building services. Partnerships with companies like Igenomix, who are committed though-leaders like we are, benefit our patients and those seeking to grow their families with the help world-class reproductive genetic testing and counseling services," says Andrew Mintz, CEO at Pinnacle Fertility. PGT is an elective treatment option that can be used to identify embryos at risk of having a specific genetic or chromosomal condition and is available for patients at all fertility clinics within the Pinnacle network. Igenomix offers the most comprehensive portfolio of infertility treatments for genetics and was the first organization to launch non-invasive PGT-A services. Patients who choose to use PGT as part of their treatment plan receive complementary pre- and post-test genetic counseling to help guide and educate them on their options and results. "Bringing Igenomix onboard is an exciting opportunity for our patients to seamlessly have access to genetic testing and counseling services, such as PGT at our fertility clinics," shares Dr. Dr. Priya Maseelall from Reproductive Gynecology and Infertility "The genetic counselors are perfectly integrated into our programs and champion our patients' success like we do." Patients electing to use PGT, undergo in vitro fertilization (IVF) to create embryos, and then cells are removed from each embryo for genetic testing. Embryos with normal results are selected to be transferred into the uterus in hopes of achieving a pregnancy and delivering a child without a genetic condition. By utilizing PGT, genetic diseases can be prevented. In addition, studies have shown that PGT can not only improve success rates but also provide optimism and peace of mind during pregnancy and after birth. About Pinnacle Fertility
Pinnacle Fertility is the nation's fastest-growing physician-centric fertility care platform, supporting high-performing fertility clinics and comprehensive fertility service providers nationwide. Under a united mission of fulfilling dreams by building families, Pinnacle clinics offer innovative technology and processes, compassionate patient care, and comprehensive fertility treatment services, ensuring families receive a high-touch experience on their path to parenthood. For more information about Pinnacle Fertility, visit pinnaclefertility.com
About Igenomix
Igenomix is a global leader in reproductive genetic testing with laboratories in 23 countries and assisting hundreds of thousands of patients per year worldwide. As part of Vitrolife Group, the company is recognized for its R&D expertise and quality of service. In the US, Igenomix has proven to be the best-in-class when comes to credibility, consistency on their results, automatization of their laboratories and the most important, patient care. Learn more about Igenomix at Igenomix.com
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PINNACLE FERTILITY PARTNERS WITH IGENOMIX AS THEIR EXCLUSIVE GENETICS LABORATORY AND GENETIC COUNSELING PROVIDER

Ltd, BGI, PerkinElmer Genomics, CENTOGENE N.V., CryoCell International, Fulgent Genetics, Igenomix, Veritas Intercontinental, GENEPATH, and MedGenome among others, are some of the key players operating the in the NGS newborn genetic testing /screening market. June 06, 2022 11:58 ET
Mumbai,  INDIA
Brooklyn, New York, June  06, 2022  (GLOBE NEWSWIRE) -- According to a new market research report published by Global Market Estimates, the Global NGS Newborn Genetic Testing /Screening Market is projected to grow at a CAGR of 17.5% from 2022 to 2027. Declining sequencing prices, expanding knowledge pertaining to human genetics, the growing popularity of targeted therapies, and improved genomic data management are some of the key factors that are driving market revenue. Key Market Insights
As per the application outlook, the inherited & other disorders screening/ testing segment is estimated as the highest revenue-generating segment in the 2021 NGS newborn genetic testing /screening market
Based on the sample type outlook, the Blood segment is estimated to dominate the 2021 global market in terms of revenue generation
Among the end-users, hospitals & clinics are estimated to capture maximum revenue share in the 2021 market
North America (the United States, Canada, and Mexico) market is estimated to account for a major revenue share in the global NGS newborn genetic testing /screening market from 2022 to 2027
The Asia Pacific is expected to serve as the fastest revenue-generating market during the forecast period
LifeCell International Pvt. Ltd, BGI, PerkinElmer Genomics, CENTOGENE N.V., CryoCell International, Fulgent Genetics, Igenomix, Veritas Intercontinental, GENEPATH, and MedGenome among others, are some of the key players in the NGS newborn genetic testing /screening market
Request a Sample Copy of the report @ https://www.globalmarketestimates.com/market-report/ngs-newborn-genetic-testing-screening-market-3831
Sample Type Outlook (Revenue, USD Million, 2022-2027)
Blood
Inherited & Other Disorders Screening/ Testing
Pharmacogenomics
Hospitals & Clinics

Global NGS Newborn Genetic Testing /Screening Market Size

patients are faced with a growing list of costly “add-ons.” For one such test, some say more robust research is needed to support its effectiveness. Read in app
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At her doctor’s suggestion, Nathalie Carpenter used an endometrial receptivity analysis ahead of two in vitro fertilization cycles: One worked, but the other failed. Now, she wonders if the test was effective.Credit...Yehyun Kim for The New York Times
By Amy Klein
Dec. 18, 2021, 5:00 a.m. ET
For patients undergoing in vitro fertilization, there is a common test to help determine the best time to transfer the embryo for a successful pregnancy. But new research has patients and doctors questioning whether the test — one of a growing number of expensive “add-ons” for I.V.F. patients — is effective for first-time patients. The test, called an endometrial receptivity analysis, takes a biopsy of the interior lining of the uterus. Then a lab analyzes the tissue for more than 200 genes to predict the best time to place the embryo in the uterus, according to the test’s manufacturer, Igenomix. The study , whose findings were published in September, compared live birthrates for first-time I.V.F. patients who had the E.R.A. to those who did not, and researchers found no difference between the two groups. In other words, the test does not improve chances of achieving an ongoing pregnancy in first-time patients, according to the findings. The research, which was sponsored by Igenomix and has not been peer-reviewed or published in full, also noted that more studies were needed to assess whether the test could be beneficial for patients who have had multiple failed transfers. The study was led by researchers from Shady Grove Fertility, which has more than 40 clinics across the United States. “It doesn’t improve the live birthrates for all women,” said Dr. Nicole Doyle, the study’s lead researcher and a reproductive endocrinologist at Shady Grove. “We had hoped for better results, but from a cost benefit, it’s not worth it,” she said of the test, which can cost patients up to $1,000. “This type of study should have been done earlier,” said Dr. Eric Forman, the medical and laboratory director at Columbia University’s Fertility Center. He said the test had been used tens of thousands of times in the United States since it became available in 2011. Some clinics offer the test for all patients, while others recommend it for those with failed cycles. Many patients request the test after reading about it in online forums. Dr. Aimee Eyvazzadeh, a reproductive endocrinologist in San Ramon, Calif., said she offered the test to all patients, and about half of her first-time patients opted to do it. “They feel so empowered by having the option,” she said. The Shady Grove study offered 767 first-time I.V.F. patients a free E.R.A. before transfer. (Genetic tests ruled out any failures involving an abnormal embryo.) The patients each had one embryo transferred; half used the test and the other half did not. The results found that just over 54 percent of the group that used the test had an ongoing pregnancy, compared with just over 63 percent of the control group. Igenomix said in an emailed statement that despite funding the research, the company had not had access to the raw data and was waiting for it to be published in a peer-reviewed journal before commenting on the results. The company, which was acquired by Vitrolife in July, said that 25 other studies — 16 internal and nine independent — supported use of the test. In reality, the existing body of data shows mixed results about the test’s effectiveness. A 2018 independent study of patients with two or fewer previous failed transfers found that the test did not improve pregnancy outcomes, but the study used only a small sample of participants. One Igenomix study from 2013 found that one in four women with repeated I.V.F. failure had a displaced window of implantation and concluded that those patients could benefit from using the test. A randomized clinical trial sponsored by the company from 2020 used a sample of mostly first-time patients, with some who had experienced up to a few failed attempts. The trial concluded that those who used the test had a “significant improvement” in live birthrates, but did not differentiate between first-time patients and those with previous failed transfers. Some scientists have also criticized the study’s methodology as flawed. The Igenomix statement said that given the latest Shady Grove study, more research was needed to determine whether the test “could be clinically useful in all patients at the first appointment.”
Dr. Doyle and her team’s findings underscore critics’ ongoing concerns about the need for greater regulation of the I.V.F. industry. “It’s both irresponsible and unethical for clinics to sell I.V.F. add-ons that are scientifically unproven,” said Pamela Mahoney Tsigdinos, a patient advocate and the author of “Silent Sorority.”
While the test is certified and regulated by the Centers for Medicare and Medicaid Services, it is not approved by the Food and Drug Administration. The E.R.A. is considered a laboratory-developed test , according to Igenomix, a category that can bypass F.D.A. scrutiny. (This same loophole allowed Theranos , the blood testing start-up founded by Elizabeth Holmes , to evade the agency’s oversight. Ms. Holmes is on trial for fraud charges .) is a costly endeavor with no guarantee of success. A single I.V.F. cycle can exceed $20,000, according to data from FertilityIQ , a company that provides reviews of fertility clinics. Most people need at least three to four I.V.F. cycles to be successful. There were almost 330,000 assisted reproductive technology cycles (which includes I.V.F. and egg freezing) performed in the United States in 2019, according to preliminary data from the Centers for Disease Control and Prevention, with nearly 78,000 patients giving birth. “I.V.F. has reached maturity as a technology and we’re approaching the limits of its efficacy,” said Dr. Andrea Vidali, a reproductive immunologist and repeat miscarriage specialist in New York. He believes add-ons like the E.R.A. are a result of an industry focused on “troubleshooting I.V.F. failure.” He said that doctors adopted the test because “patients don’t want to be told they have unexplained infertility when they ask for a reason as to why their I.V.F. transfer failed, and they are looking for answers.”
Patients undergoing I.V.F. are presented with a list of add-ons “with no ability” to assess the value, according to David Sable, a venture capital fund manager and reproductive endocrinologist. In light of the new research, some fertility doctors are reconsidering the test’s use on first-time patients, while other doctors are further dissuaded from using it at all. “We have always discouraged the E.R.A. test,” said Dr. Peter Klatsky, a founder of Spring Fertility, which has clinics in California, New York and Vancouver. He has observed the test’s popularity grow in recent years. “This study makes it easier to explain why we do not recommend this test when patients have read positive testimonials online,” he said. Some patients who had ongoing pregnancies after using the test are now unsure of whether their success was a result of the test. Nathalie Carpenter, the 42-year-old founder of a wellness marketing agency and a community advocate for infertility in Connecticut, received the test ahead of two I.V.F. cycles, each years apart. The first resulted in a daughter; the second failed. She wonders now whether the E.R.A. was effective. But at the time, she said, “I trusted my doctor; I didn’t question it.”
Some patients remain hopeful that the test could tip the scale toward a successful pregnancy regardless of the ambiguous data. When Rhian Thomas, a 39-year-old television producer in New York, was preparing for her first embryo transfer at the Columbia University Fertility Center, she told Dr. Forman, the center’s medical and laboratory director, that she wanted an E.R.A., even though he was skeptical. Having experienced multiple miscarriages before, Ms. Thomas said she wanted to “go through every test on the planet” for the best chance of pregnancy. The transfer after the test resulted in a son, who is now seven months old. Despite the new study, Ms. Thomas said she was glad she did the test and would do it again. “If it didn’t work out, I would wonder, ‘What if the implantation window was off?’” she said. “You want control. And that’s what the E.R.A. does — it gives an element of control over these things.”
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A Popular Test Claims to Boost I.V.F. Success. The Science Is Unclear.

Currently, Fertty performs 1,000 treatments a year, a figure it expects to double in a matter of three years. Fertty closed 2020 with a turnover of $3.4 million (€2.9 million), compared to $2.8 million (€2.4 million) in 2019. The Barcelona-based assisted reproduction clinic has just sealed a global agreement with the Igenomix group to advance in genetic research. 0
Fertty is looking for allies to continue growing in the fertility sector. The Barcelona-based assisted reproduction clinic has just sealed a global agreement with the Igenomix group to advance in genetic research, as confirmed by Miguel Ángel Checa, founder of the company. The agreement, the amount of which has not been disclosed, will serve to “develop technology in genetics and endometrium and to do so jointly”, explains the founder of this clinic located at number 25 Ausiàs March street in the Catalan capital. In this way, Fertty joins forces with one of the leaders in the assisted reproduction sector, which last July was acquired by Vitrolife. The investment fund behind Igenomix, EQT, decided to transfer the assisted reproduction group for more than $1.4 billion (€1.2 billion). Founded in 2011 as a spin-off from IVI Group, Igenomix is a global benchmark in women’s health and reproductive genetics services for in vitro fertilization (IVF) and rare disease clinics. It has approximately 560 employees and is headquartered in Valencia, with additional laboratories in some 20 countries. Read more on the subject and find the latest finance news in the world with the Born2Invest mobile app. Fertty is confident that in three years the percentage of international patients will be 40%
This is not Fertty’s only recent project. The Catalan clinic also partnered with Overture Life, the Madrid-based group specializing in assisted reproduction led by Martín Varsavsky, the Argentine businessman who made lofts fashionable in New York and revolutionized telecommunications with Viatel in the United States, and with Jazztel, Ya, and Fon in Europe. In 2020, an agreement in principle was announced between both parties and now what Checa defines as an “experimental project in research and development (R&D)” is already underway. Specifically, Fertty will implement the products that Overture Life is developing, adds the founder of the Barcelona-based company. Overture Life is the Jazztel founder’s fertility project. The company managed to raise twenty million dollars $21 million (€18 million) from some of Silicon Valley’s heavyweights. Among them are Khosla Ventures, the fund of Vinod Khosla, founder of Sun Microsystems and a historic figure in the tech world; the Wojcicki sisters, the CEO of 23andMe, and Menlo Park’s Felicis Ventures. Fertty closed 2020 with a turnover of $3.4 million (€2.9 million)
Beyond partnerships, another of Fertty’s objectives is to focus on the international patient. Currently, 95% of clients are national, but the company hopes that in three years this percentage will be 40%, compared to 60% of national patients. To achieve this goal, the company has invested one million euros in the expansion of its center, where it will add 200 square meters to create “a virtual reality visit area” aimed at foreign patients. At present, the company performs 1,000 treatments a year, a figure it expects to double in a matter of three years. Fertty closed 2020 with a turnover of $3.4 million (€2.9 million), compared to $2.8 million (€2.4 million) in 2019, and the forecast for 2021 is to reach revenues of four million euros. Miguel Ángel Checa is the leader of this project. The founder is a graduate in Medicine from the Universitat Autònoma de Barcelona and coordinator of the International Master’s Degree in Reproductive Medicine from the same center. In addition, Checa is the head of the section of gynecological endocrinology and human reproduction at the Hospital del Mar in Barcelona. Fertty’s other partner, Juan José Espinós, who served as coordinator of the reproductive endocrinology unit at the Hospital de la Santa Creu i Sant Pau in Barcelona. DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our  disclaimer  for more information. This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these  important disclosures . First published in  PlantaDoce , a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail. Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Fertty Signs an Agreement with Igenomix Group to Advance in Genetics

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group. Ferring Pharmaceuticals specializes in the areas of reproductive medicine and women’s health, urology and gastroenterology.

Ferring Pharmaceuticals

Ferring Pharmaceuticals and Igenomix collaborate to advance care in reproductive medicine and maternal health .

Ferring and Igenomix collaborate to advance care in reproductive medicine and maternal health - Ferring Pharmaceuticals

Boston IVF is an experienced fertility center with more than 50,000 babies born since 1986. The company has a center for cutting-edge reproductive technologies coupled with exceptional care and has pregnancy rates approaching 60% in certain patient groups and 13 locations throughout New England -- including Maine, Rhode Island and New Hampshire.

Boston IVF

Good Start Genetics offers preconception carrier screening tests for all ACOG- and ACMG- recommended disorders, as well as an extended Ashkenazi Jewish test menu. The company's test menu was designed with input from an expert panel of reproductive health physicians and genetic counselors from across the country. Good Start has designed its test menu for easy adherence to society guidelines. The company's next-generation sequencing (NGS) platform is a cost-effective platform accessible for routine genetic carrier screening. Utilizing NGS, Good Start will evaluate patient DNA samples to detect both common and novel disease-causing mutations associated with recessive genetic disorders, hence providing a depth of analysis far beyond current targeted mutation analysis platforms.

Good Start Genetics

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Companies involved in the capture, sequencing, and/or analysis of genomic, transcriptomic, proteomic, and/or metabolomic data

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Startups focused on providing products and services catering to women's health and wellbeing.

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Igenomix is a Spain-based provider of genetic testing services for reproductive health patients and clinics. Igenomix supports thousands of patients every year in their reproductive journey through a diversified portfolio of IVF (In Vitro Fertilization) services covering every phase of fertility treatment.On July 8, 2021, Igenomix was acquired by Vitrolife.79M.

Name	Antonio Trius
Firm
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Other Seats	Igenomix

Name	Work History	Title	Status
Gregg Fergus	4Catalyzer, Ion Torrent Systems, Baird Capital Partners, Fujifilm Cellular Dynamics, Affymetrix, GE Healthcare, and VWR International	Founder	Current
Carlos Simón	Stanford University School of Medicine, and Yale University	Founder	Former

Name	Gregg Fergus	Carlos Simón
Work History	4Catalyzer, Ion Torrent Systems, Baird Capital Partners, Fujifilm Cellular Dynamics, Affymetrix, GE Healthcare, and VWR International	Stanford University School of Medicine, and Yale University
Title	Founder	Founder
Status	Current	Former

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