Validation study published in the Journal of the American Society of Nephrology (JASN) showed improved sensitivity with quantification vs. dd-cfDNA fraction alone
AUSTIN, Texas, Sept. 9, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in transforming care through genetic and cell-free DNA (cfDNA) testing, today announced the launch of Prospera with Quantification, the only cfDNA test for kidney rejection that provides three values — the quantity of donor-derived cfDNA (dd-cfDNA), fraction of dd-cfDNA and total cfDNA on every report. Combining these three metrics has been shown to improve sensitivity when evaluating transplant rejection, compared to using dd-cfDNA fraction alone. Currently, other commercially available cfDNA tests that assess transplant rejection only report the fraction of dd-cfDNA.
A recent peer-reviewed paper published in JASN1 showcased improved performance from Prospera with Quantification in 41 kidney transplant patients, 9 of whom had rejection. Incorporating the quantity of dd-cfDNA with the fraction of dd-cfDNA improved the sensitivity of the Prospera test from 7/9 to 9/9 in cases of active rejection, confirmed with renal biopsy.
“Total cell-free DNA is often elevated during viral infections and other complicated scenarios due to increases in the host-derived fraction,” said Suphamai Bunnapradist, M.D., transplant nephrologist at the University of California-Los Angeles and senior author of the JASN study. “Consequently, the percentage of dd-cfDNA can be artificially depressed in these scenarios, leading to false negative results.” Dr. Bunnapradist continued, “The absolute quantification of dd-cfDNA in the sample is a game-changer as it makes the test more robust in challenging clinical scenarios, while boosting its sensitivity.”
The clinical utility and increase in sensitivity have now been seen in six independent datasets, including in the large international, multi-site, prospective Trifecta study,2 which is expected to be published in early 2022. Prospera with Quantification is now commercially available through Natera’s laboratory.
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 pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
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 email@example.com
- Bunnapradist S, et al. Using both the fraction and quantity of donor-derived cell-free DNA to detect kidney allograft rejection, J Amer Soc Nephrology 2021, in press
- Halloran P, et al. Manuscript in preparation, anticipated 2022
SOURCE Natera, Inc.