By writer to www.montereycountyweekly.com
SAN CARLOS, Calif., Could 4, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and world chief in cell-free DNA testing, immediately 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 12 months interval to look at the utility of the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant evaluation check to precisely establish 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 the moment enrolled.
“The ProActive trial is a big, potential registry research designed to offer useful insights on medical biomarkers, biopsy utilization and medical outcomes. Participation by prime transplant facilities within the U.S. is resulting in rising enrollment and accumulation of vital knowledge. It’s notable that is taking place even throughout these tough occasions 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 sphere. I’m assured this trial will enhance the care of our sufferers and look ahead to the outcomes,” mentioned Jonathan Bromberg, M.D., Professor of Surgical procedure and Microbiology and Immunology, Vice Chair for Analysis on the College of Maryland College of Medication, 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 want for extra correct, non-invasive testing strategies, which Prospera fulfills by its potential to establish rejection with larger accuracy than first technology dd-cfDNA assessments and present requirements of care,”1,2 mentioned Paul Billings, M.D., Ph.D., Chief Medical Officer and SVP of Medical Affairs at Natera.
To study extra concerning the ProActive research, click on here.
In regards to the Prospera dd-cfDNA Organ Transplant Check
The Prospera check leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) expertise to establish allograft rejection non-invasively and with excessive precision and accuracy, with out the necessity for prior donor or recipient genotyping. The check works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) within the recipient’s blood. It might be utilized by physicians contemplating the analysis of lively 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 medical presentation. The check described has been developed and its efficiency traits decided by the CLIA-certified laboratory performing the check. The check has not been cleared or authorized by the US Meals and Drug Administration (FDA). Though FDA has usually not enforced the premarket overview and different FDA authorized necessities for laboratory-developed assessments within the U.S., certification of the laboratory is required underneath CLIA to make sure the standard and validity of the assessments.
Natera is a world chief in cell-free DNA testing. The mission of the corporate is to alter the administration of illness worldwide with a give attention to reproductive well being, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory licensed underneath the Scientific Laboratory Enchancment Amendments (CLIA) in San Carlos, Calif. It presents proprietary genetic testing companies 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. Comply with Natera on LinkedIn.
All statements apart from statements of historic details contained on this press launch are forward-looking statements and should not a illustration that Natera’s plans, estimates, or expectations might 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 potential to efficiently enhance demand for and develop revenues for our product choices, our potential to finish medical research or whether or not the outcomes of such research will help the usage of 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. Further dangers and uncertainties are mentioned in higher element in “Danger Elements” in Natera’s current filings on Kinds 10-Okay and 10-Q and in different filings Natera makes with the SEC once in a while. 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, Natera, Inc., firstname.lastname@example.org
- Sigdel TK, Archila FA, Constantin T, et al. Optimizing Detection of Kidney Transplant Damage 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.