Natera Announces Results of Large, Multi-Center Clinical Experience Study Showing Excellent Positive Predictive Value of the Prospera™ Kidney Test
AUSTIN, Texas, Feb. 17, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the results of a large, real-world study confirming strong performance of its Prospera donor-derived cell-free DNA (dd-cfDNA) test in assessing rejection for kidney transplant patients.
The study, published in Transplantation Proceedings, reports the real-world impact of dd-cfDNA on patient management in a multi-center, real-world clinical cohort, including 879 patients evaluated from 33 participating clinics. Eighteen of the 28 patients with biopsy-matched high-risk Prospera dd-cfDNA test results were confirmed to have active rejection, demonstrating a reported 64% positive predictive value (PPV). Further, six of the remaining 10 patients had borderline TCMR or other pathologic conditions consistent with other types of kidney injury. As summarized in the publication, "The data indicate that incorporating dd-cfDNA testing into practice may improve physician decision making regarding renal allograft recipients."
"The Prospera dd-cfDNA test continues to solidify its role as an important tool for monitoring the graft health of transplant patients," said Yasir Qazi, M.D., associate professor of clinical medicine and medical director of the kidney-pancreas transplant outreach and fellowship program at the Keck School of Medicine of USC, principal investigator and lead author of the study. "It was exciting to see a strong performance in real-world clinical settings across leading institutions."
This study adds to the growing body of evidence supporting Prospera dd-cfDNA testing, including the Trifecta study, the largest prospective, biopsy-matched, multi-center study to date in the field of kidney transplantation, currently submitted for publication.
About the Prospera test
The Prospera test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 firstname.lastname@example.org
SOURCE Natera, Inc.