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SAN CARLOS, Calif., Could 4, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and world chief in cell-free DNA testing, in the present day introduced the achievement of key recruitment milestones within the ProActive registry research and success within the Prospera early entry program.
The ProActive research will comply with 3,000 kidney transplant sufferers over a 3 to 5 yr interval to look at the utility of the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant evaluation take a look at to precisely determine organ rejection. The research is outpacing Natera’s enrollment expectations with 18 prime transplant facilities already activated, extra coming on-line within the close to future, and 145 sufferers at present enrolled.
“The ProActive trial is a big, potential registry research designed to supply precious insights on scientific biomarkers, biopsy utilization and scientific outcomes. Participation by prime transplant facilities within the U.S. is resulting in rising enrollment and accumulation of necessary information. It’s notable that is taking place even throughout these troublesome instances for our transplant sufferers and facilities throughout the COVID-19 pandemic, demonstrating the fortitude and dedication of transplant professionals to the way forward for the sector. I’m assured this trial will enhance the care of our sufferers and sit up for the outcomes,” stated Jonathan Bromberg, M.D., Professor of Surgical procedure and Microbiology and Immunology, Vice Chair for Analysis on the College of Maryland College of Drugs, and Principal Investigator of the ProActive research.
Within the Prospera early entry program, Natera has acquired assessments from 45% of the highest 50 and 37% of the highest 100 transplant facilities by quantity. “The robust curiosity in Prospera and the numerous variety of prime facilities ordering assessments throughout the early entry program displays a need for extra correct, non-invasive testing strategies, which Prospera fulfills by its capacity to determine rejection with greater accuracy than first technology dd-cfDNA assessments and present requirements of care,”1,2 stated Paul Billings, M.D., Ph.D., Chief Medical Officer and SVP of Medical Affairs at Natera.
To study extra in regards to the ProActive research, click on here.
Concerning the Prospera dd-cfDNA Organ Transplant Take a look at
The Prospera take a look at leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) expertise to determine allograft rejection non-invasively and with excessive precision and accuracy, with out the necessity for prior donor or recipient genotyping. The take a look at works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) within the recipient’s blood. It could be utilized by physicians contemplating the analysis of energetic rejection, serving to to rule in or out this situation when evaluating the necessity for diagnostic testing or the outcomes of an invasive biopsy. Prospera has been clinically and analytically validated for efficiency no matter donor relatedness, rejection kind, and scientific presentation. The take a look at described has been developed and its efficiency traits decided by the CLIA-certified laboratory performing the take a look at. The take a look at has not been cleared or authorized by the US Meals and Drug Administration (FDA). Though FDA has usually not enforced the premarket evaluation and different FDA authorized necessities for laboratory-developed assessments within the U.S., certification of the laboratory is required below CLIA to make sure the standard and validity of the assessments.
Natera is a worldwide chief in cell-free DNA testing. The mission of the corporate is to vary the administration of illness worldwide with a deal with reproductive well being, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory licensed below the Scientific Laboratory Enchancment Amendments (CLIA) in San Carlos, Calif. It affords proprietary genetic testing providers to tell obstetricians, transplant physicians, oncologists, and most cancers researchers, together with biopharmaceutical corporations, and genetic laboratories by its cloud-based software program platform. For extra info, go to natera.com. Observe Natera on LinkedIn.
All statements aside from statements of historic information contained on this press launch are forward-looking statements and usually are not a illustration that Natera’s plans, estimates, or expectations will likely be achieved. These forward-looking statements signify Natera’s expectations as of the date of this press launch, and Natera disclaims any obligation to replace the forward-looking statements. These forward-looking statements are topic to identified and unknown dangers and uncertainties that will trigger precise outcomes to vary materially, together with with respect to the near- and long-term impression of the COVID-19 pandemic on our enterprise and outcomes of operations, our efforts to develop and commercialize new product choices, our capacity to efficiently improve demand for and develop revenues for our product choices, our capacity to finish scientific research or whether or not the outcomes of such research will assist using our product choices, our expectations of the reliability, accuracy and efficiency of our screening assessments, or of the advantages of our screening assessments and product choices to sufferers, suppliers and payers. Extra dangers and uncertainties are mentioned in larger element in “Danger Components” in Natera’s latest filings on Varieties 10-Ok and 10-Q and in different filings Natera makes with the SEC occasionally. These paperwork can be found at investor.natera.com and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Company Advertising and marketing, Natera, Inc., [email protected]
- Sigdel TK, Archila FA, Constantin T, et al. Optimizing Detection of Kidney Transplant Harm by Evaluation of Donor-Derived Cell-Free DNA through Massively Multiplex PCR. J Clin Med. 2019;8(1):19.
- Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and Energetic Rejection in Kidney Allografts. J Am Soc Nephrol. 2017;28(7):2221-2232.
SOURCE Natera, Inc.
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