Natera Publishes VALID Study Results for Prospera Lung dd-cfDNA Transplant Rejection Assessment Test

AUSTIN, Texas, April 7, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the publication of the VALID study¹, showcasing its Prospera™ Lung donor-derived cell-free DNA (dd-cfDNA) test in assessing rejection and allograft injury in lung transplant patients.

The blinded prospective clinical validation, published in Transplant Direct, analyzed 195 biopsy-matched samples from 103 patients with cohort demographics that closely mirrored those reported to the Scientific Registry of Transplant Recipients (SRTR). Prospera Lung dd-cfDNA results were analyzed in connection with various complications from lung transplantation, including acute rejection (AR, includes both acute cellular rejection and antibody mediated rejection), chronic lung allograft dysfunction/neutrophilic-responsive allograft dysfunction (CLAD), and allograft infection (INFXN). The Prospera test exhibited outstanding performance data across all clinical events, including:

• AR vs. Stable; 0.91 AUC
• AR+CLAD+INFXN vs. Stable; 0.76 AUC

"These data are a promising demonstration of the value that the Prospera Lung dd-cfDNA test can provide in identifying lung transplant complications," said Brian Keller, M.D., Ph.D., associate professor of medicine at The Ohio State University Wexner Medical Center, and principal investigator of the study. "It is exciting to add the Prospera Lung dd-cfDNA test in our diagnostic toolbox as we strive to improve surveillance, treatment, and outcomes for these patients."

The Prospera Lung test is already utilized in roughly 25% of U.S. lung transplant centers after its clinical launch in late 2021. Prospera is also being evaluated in a first of its kind clinical utility study, the multi-center randomized-controlled clinical trial, LAMBDA 001.

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 inform 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]

References

1. Rosenheck JP, Ross DJ, Botros M, et al. Clinical Validation of a Plasma Donor-derived Cell-free DNA Assay to Detect Allograft Rejection and Injury in Lung Transplant. Transplant Direct. 2022;8(4):1317.

SOURCE Natera, Inc.