Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that it has received commercial insurance coverage for its Prospera Heart and Prospera Kidney tests from one of the largest Blue Cross Blue Shield (BCBS) plans in the U.S. Prospera is a non-invasive blood test that analyzes donor-derived cfDNA (dd-cfDNA) to evaluate the risk of organ transplant rejection.

The coverage policy includes serial testing with Prospera to assess graft status and identify the risk of rejection following a kidney or heart transplant. Commercially insured patients have historically had limited access to dd-cfDNA testing, but that is changing as a result of recent medical society endorsements and guidelines that support the use of dd-cfDNA.^1-3

“We are thrilled with this new policy, which increases access to Prospera for commercially insured transplant patients and adds to the existing Medicare coverage in heart, kidney, and lung,” said Bernie Tobin, general manager of organ health at Natera. “Improving long-term outcomes for this population starts with more accurate and non-invasive tools to identify potential graft issues earlier.”

Natera and its academic partners have published significant peer-reviewed evidence supporting the clinical utility of Prospera. Natera’s organ health products have been featured in 39 peer-reviewed manuscripts, which have been published or accepted in top journals, including the recently accepted publications from the Trifecta Heart, DTRT, and ProActive studies. In addition, Natera has completed enrollment in the PEDAL and MOTR trials. These are both multi-site, prospective studies designed to provide novel evidence supporting the clinical utility of Prospera, with expected publication in 2024.

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. 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, our expectations of the benefits of our tests and product offerings to patients, providers and payers, or coverage and reimbursement determinations from third-party 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. American Society of Transplant Surgeons. ASTS Statement on donor-derived cell-free DNA (dd cf-DNA). asts.org. https://asts.org/docs/default-source/position-statements/dd-cfdna-position-statement.pdf. Accessed March 7, 2024.
2. Kobashigawa J, Hall S, Shah P, et al. The evolving use of biomarkers in heart transplantation: consensus of an expert panel. Am J Transplant. 2023;23(6):727-735. doi: https://doi.org/10.1016/j.ajt.2023.02.025.
3. The European Society for Organ Transplantation. ESOT TLJ Consensus Conference Highlights Report. esot.org. https://esot.org/wp-content/uploads/2023/03/EM012464_TLJ_3_0_Scientific_Highlights_Report_230316_V0-7_SMB.pdf. Accessed March 7, 2024.

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