Trifecta Study Demonstrates Prospera™ Kidney dd-cfDNA Test Outperforms DSA in Predicting Antibody Mediated Rejection

AUSTIN, Texas, Oct. 4, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced the publication of the latest data from the Trifecta study in Transplantation, found here. The investigators found that in predicting antibody mediated rejection (AMR), donor-derived cell-free DNA (dd-cfDNA) testing with the Prospera Kidney test was superior to the current standard of care, donor-specific antibody (DSA) testing.

In the study, both components of the Prospera two-threshold algorithm, dd-cfDNA donor fraction (AUC 0.84) and estimated amount of dd-cfDNA (AUC 0.85), outperformed DSA (AUC 0.66) in identifying AMR. Societal guidelines currently recommend DSA testing as standard practice for monitoring AMR, highlighting a compelling consideration for the broader use of dd-cfDNA in kidney transplantation.

This manuscript is the latest out of the Trifecta study, led by principal investigator Phil Halloran, M.D., Ph.D., director of the Alberta Transplant Applied Genomics Centre. The investigators assessed dd-cfDNA donor fraction, estimated amount of dd-cfDNA and DSA-status for 280 samples from kidney transplant recipients matched to kidney biopsies evaluated by both RNA-based molecular pathology (Molecular Microscope® Diagnostic System, "MMDX") and histology (Banff Classification of Allograft Pathology, 2019).

"These data further strengthen the case to incorporate dd-cfDNA into routine practice for the assessment of solid organ transplant rejection," said Dr. Halloran. "DSA has been a staple in the transplant physician’s repertoire for a long time, but it’s increasingly clear that we also need to adopt newer technologies, like dd-cfDNA, to develop a more complete clinical picture of patients’ graft status."

Twelve peer-reviewed manuscripts have been published since 2021 featuring Natera’s Organ Health products, including another recent publication from the Trifecta study validating the novel two-threshold algorithm in the Prospera test.

About the Prospera test

The Prospera^TM 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.

About Natera

Natera^TM 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.

Forward-Looking Statements

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, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our 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: Brian Symmons, SVP of Marketing and Corporate Affairs, Natera, Inc., pr@natera.com

SOURCE Natera, Inc.