Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera™ Heart dd-cfDNA Test for Heart Transplant Recipients

Prospective, multi-center Trifecta-Heart and DTRT-2 studies demonstrate excellent performance of the Prospera Heart test for detecting rejection in adults and pediatrics

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced the publication of two major studies, DTRT-2 and Trifecta-Heart, showcasing the ability of the Prospera Heart donor-derived cfDNA (dd-cfDNA) test to detect rejection in adult and pediatric heart transplant recipients. These are the second and third peer-reviewed publications evaluating Natera’s technology for use in heart transplantation.

“We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “The consistent, excellent performance of Prospera Heart across multiple independent studies should inspire confidence among transplant physicians to leverage Prospera as part of standard patient care.”

The Prospera Heart test was launched in 2021 and received Medicare coverage following the 2022 publication of a multi-site clinical validation study, the DEDUCE study, in the Journal of Heart and Lung Transplantation. That study showed the Prospera Heart test had an overall area under the curve (AUC) of 0.86 for identifying acute rejection in over 800 samples from 200 adults with heart transplants.

The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation, was sponsored by the National Institutes of Health (NIH). A total of 487 samples from 160 heart transplant recipients were evaluated, of which 78 were pediatric and 82 were adult patients. The Prospera Heart test demonstrated outstanding performance in detecting rejection, as determined by histopathology from endomyocardial biopsies (EMBs), with an AUC of 0.82 in adult patients and 0.83 in pediatric patients. The study reported a negative predictive value (NPV) of 92% for adult patients and 99% for pediatric patients, supporting the intended use of Prospera Heart as a rule-out test to help obviate surveillance biopsy procedures.

“DTRT-2 is a landmark study that further demonstrates that the Prospera Heart test is a highly reliable, non-invasive tool for detecting heart transplant rejection in adult patients, and now solidifies that outstanding performance for pediatric patients as well,” said Shriprasad R. Deshpande, MBBS, MS, director of the Advanced Cardiac on Therapies and Heart Transplant Program, Children’s National Hospital, and lead author of the study. “Based on these findings, I believe the Prospera Heart test has the potential to greatly reduce the number of invasive surveillance biopsies in children and enhance their quality of life.”

The Trifecta-Heart study had its initial publication last week in Transplantation and has an upcoming oral presentation at the 2024 International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting. This initial readout included 137 plasma samples analyzed using the Prospera Heart test, correlated with matched EMBs analyzed using the Molecular Microscope® Diagnostic System (MMDx), a more objective reference standard for rejection compared to histopathology. Based on data collected in the first 18 months, the Prospera Heart test was highly accurate in distinguishing acute rejection from non-rejection, with an AUC of 0.90 and a NPV of 96%. These results affirm the strong performance of Prospera Heart shown in the DEDUCE study.

Roughly 4,100 heart transplants are performed each year in the U.S., including about 490 pediatric recipients in 2022.¹ Biopsies, which are the current standard of care for heart transplant surveillance, have a complication rate ranging between 1-5%.^2-6 Further, due to modern immunosuppression regimens, acute rejection rates, as detected by surveillance biopsies, are now lower than the rate of biopsy complications.⁷ This highlights the imbalance in risk versus reward and argues in favor of a non-invasive alternative to monitor for rejection.

These latest data come just before the 2024 ISHLT Annual Meeting, where Natera will deliver one oral presentation and six poster presentations related to its Prospera Heart and Prospera Lung tests.

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.

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 180 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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, or our expectations 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.

References

1. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report: Heart. U.S. Department of Health and Human Services, Health Resources and Services Administration. 2024. Accessed April 4, 2024. https://srtr.transplant.hrsa.gov/annual_reports/2022/Heart.aspx#fig:HRtx-adult-counts-all
2. Bermpeis K, Esposito G, Gallinoro E, et al. Safety of right and left ventricular endomyocardial biopsy in heart transplantation and cardio-myopathy patients. JACC Heart Fail. 2022;10:963–973.
3. Strecker T, Rösch J, Weyand M, et al. Endomyocardial biopsy for monitoring heart transplant patients: 11-years-experience at a German heart center. Int J Clin Exp Pathol. 2013;6:55–65.
4. Deckers JW, Hare JM, Baughman KL. Complications of transvenous right ventricular endomyocardial biopsy in adult patients with cardio-myopathy: a seven-year survey of 546 consecutive diagnostic procedures in a tertiary referral center. J Am Coll Cardiol. 1992;19:43–47.
5. Hamour IM, Burke MM, Bell AD, et al. Limited utility of endomyocardial biopsy in the first year after heart transplantation. Transplantation. 2008;85:969–974.
6. Hull JV, Padkins MR, Hajj SE, et al. Risks of right heart catheterization and right ventricular biopsy: a 12-year, single-center experience. Mayo Clin Proc. 2023;98:419–431.
7. Cusi V, Vaida F, Wettersten N, et al. Incidence of Acute Rejection Compared With Endomyocardial Biopsy Complications for Heart Transplant Patients in the Contemporary Era. Transplantation. 2023. Epub ahead of print. PMID: 38098137.

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