New publication shows that Prospera-guided care helped >75% of low-risk patients safely avoid routine transbronchial biopsies performed at 9 months

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center (OSU-WMC), was initiated to explore whether donor-derived cell-free DNA (dd-cfDNA) surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients following lung transplantation.

Lung transplant patients are typically monitored with transbronchial biopsies – at one, three, six, nine, and 12 months after transplantation. These procedures are invasive, costly and associated with significant morbidity¹.

As transplant volumes increased at OSU-WMC, the center launched a quality assurance and performance improvement (QAPI) initiative to evaluate whether the Prospera test could allow them to safely eliminate the 9-month surveillance biopsy.

In the study, 78 lung-transplant recipients were monitored with the Prospera test for one year post-transplant. Prospera testing was incorporated at approximately 8 months to categorize patients as low risk (<1.0 % dd-cfDNA) or high risk (≥1.0 %) for rejection. Physicians could then choose to forgo the 9-month surveillance biopsy for low-risk, clinically stable patients. All participants were recommended for a protocol biopsy at 12 months post-transplant.

Key findings included:

• Physicians chose to omit the 9-month biopsy in ~75% of patients with low-risk Prospera results. For these patients over the ensuing 3 months, there was no significant difference in acute rejection rates, spirometry indices, or donor-specific antibodies compared to patients who underwent the procedure.
• At one year post-transplant, approximately 95% of patients who omitted the 9-month biopsy did not have acute rejection that needed any treatment.
• Patients who omitted the 9-month biopsy maintained lung function and immunologic stability similar to those who underwent the procedure.

“This study highlights how monitoring with Prospera can improve both the patient experience and the sustainability of transplant programs,” said Justin Rosenheck, D.O., clinical assistant professor of internal medicine at The Ohio State University Wexner Medical Center and principal investigator of the study. “These compelling results support our goal of providing more personalized and efficient medical care without compromising patient safety or outcomes.”

“The Prospera test provided actionable patient risk assessments within a structured QAPI framework,” said David Ross, M.D., senior medical director of lung transplantation and molecular diagnostics at Natera. “These data support fewer routine biopsies during dd-cfDNA surveillance while maintaining lung function and immune response. We believe that future clinical studies could further support the safe omission of protocol biopsies implementing the Prospera Lung test, ultimately reducing invasive procedural risks and burdens with optimized health.”

References

1. Huo J, Xu Y, Sheu T, Volk RJ, Shih Y-CT. Complication Rates and Downstream Medical Costs Associated With Invasive Diagnostic Procedures for Lung Abnormalities in the Community Setting. JAMA Internal Medicine. 2019;179(3):324-332.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, 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 supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. 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 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.

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