Multi-Site Clinical Validation of Prospera Heart Test Demonstrates Outstanding Performance in Assessing Heart Transplant Rejection

DEDUCE study demonstrates AUC of 0.86 in overall cohort, including more than 700 prospective samples

AUSTIN, Texas, April 13, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that its clinical validation study¹ on its donor-derived cell-free DNA (dd-cfDNA) test for the assessment of acute rejection in heart transplant patients, Prospera™ Heart, has been published in the Journal of Heart and Lung Transplantation - a leading journal with the highest impact factor in the transplantation sector².

This multi-site clinical validation, named the DEDUCE study, was conducted in partnership with the University of Utah and the University of California, San Diego and evaluated 703 prospective and 108 retrospective samples, (811 samples total) from 223 patients. The patient cohort included a large number of biopsy-confirmed rejections - 32 samples correlating to antibody mediated rejection (AMR) and 17 samples correlating to acute cellular rejection (ACR). The Prospera Heart test exhibited excellent performance with an overall 0.86 AUC for identifying acute rejection. Notably, the performance was also exceptional in the prospective arm-alone (0.87 AUC³).

"There is a critical unmet need for an accurate and less invasive approach for rejection surveillance after heart transplant," said Josef Stehlik, senior author and medical director of the Heart Transplant Program and co-chief of the Advanced Heart Failure Program at the University of Utah School of Medicine. "Incorporation of a noninvasive assay to reduce or replace the use of endomyocardial biopsy requires a very high performance standard. The Prospera Heart test demonstrated performance that I believe the clinicians will be very excited about."

The study also included an analysis on the use of dd-cfDNA concentration alone to identify rejection. dd-cfDNA concentration demonstrated an AUC of 0.88 overall, and 0.89 in the prospective cohort, highlighting the potential (upon additional studies and evaluation) to further improve the performance of the Prospera Heart test by evaluating both dd-cfDNA concentration and donor fraction.

The Prospera Heart test was launched in late 2021 and will continue to be evaluated in a variety of additional studies, including the NIH-supported DTRT study, and the Natera-sponsored DETECT trial, expected to be the first randomized controlled trial comparing dd-cfDNA surveillance to endomyocardial biopsy surveillance in patients of all risk profiles from 30 days post transplant. Combined, these trials are expected to include more than 775 heart transplant patients across multiple centers, underscoring Natera's commitment to generating robust scientific evidence.

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.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and 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, 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. Kim PJ, Olymbios M, Siu A, et al. A novel donor-derived cell-free DNA assay for the detection of acute rejection in heart transplantation. J. Heart Lung Transplant. April 2022. DOI: https://doi.org/10.1016/j.healun.2022.04.002.
2. Web of Sciences Group impact factor as reported by scijournal.org.
3. Natera data on file for performance breakdown in prospective cohort.

SOURCE Natera, Inc.

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