Medicare Extends Coverage of Natera's Signatera™ MRD Test to Muscle Invasive Bladder Cancer

AUSTIN, Texas, July 18, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it has received written confirmation from the CMS Molecular Diagnostics Services Program (MolDX) that the Signatera molecular residual disease (MRD) test has met coverage requirements for patients with muscle invasive bladder cancer (MIBC), effective April 19, 2022. To our knowledge, this represents the first coverage expansion to occur under the foundational local coverage determination (LCD) for MRD testing in solid tumors (LCD L38779), which was published in December 2021.

The decision by CMS in MIBC is based on evidence from multiple published validation studies. A study published in Nature, based on the phase III randomized IMvigor010 trial, showed that patients who tested MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy, while MRD-negative patients derived no benefit from additional systemic therapy. Another study published in the Journal of Clinical Oncology found that serial testing with Signatera detected metastatic recurrence with 100% sensitivity and 98% specificity. Both studies showed that on-treatment monitoring with Signatera can provide an early assessment of therapy effectiveness, whether in the neoadjuvant or adjuvant settings.

"This is great news for patients with bladder cancer, who face uncertain treatment decisions throughout the patient journey," said Solomon Moshkevich, general manager of oncology at Natera. "This is also a milestone for Natera, representing the first new disease indication to be covered under the foundational LCD. We look forward to working with Medicare and with the oncology community to continue incorporating Signatera MRD assessment into standard care for patients with solid tumors."

Bladder cancer is the sixth most common cancer in the United States¹ and MIBC represents 20-25% of the newly diagnosed cases.² Patients previously treated for MIBC have a high rate of recurrence, with 50% experiencing distant recurrence post-cystectomy.³ Of these, 90% of recurrences develop in the first 3 years.^4,5

"To balance the risks versus benefits of adding systemic treatments like chemotherapy to radical cystectomy, we need measures to identify which patients indeed harbor micrometastatic disease, which would allow refined shared medical decisions," said Matthew Galsky, M.D., professor of medicine (hematology and medical oncology), director of genitourinary medical oncology, co-director of the Center of Excellence for Bladder Cancer at the Tisch Cancer Institute and associate director for translational research at the Tisch Cancer Institute.

This decision adds to the existing Medicare coverage for Signatera in colorectal cancer and for pan-cancer immunotherapy monitoring.

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes Signatera's accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

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 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.

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, 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.

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]

1. National comprehensive Cancer Network, Bladder Cancer. NCCN Clinical practice guidelines in oncology (NCCN Guidelines). Version 4.2021.
2. Gakis G. Management of Muscle-invasive Bladder Cancer in the 2020s: Challenges and Perspectives. Eur. Urol. Focus. 2020;6(4):632-638.
3. Ghoneim MA, Abdel-Latif M, el-Mekresh M, et al. Radical cystectomy for carcinoma of the bladder: 2,720 consecutive cases 5 years later. J Urol. 2008;180(1):121-127.
4. Witjes JA CE, Cowman NC, et al. Guidelines on muscle invasive and metastatic bladder cancer. Eur Urol. 2015.
5. National Collaborating Centre for Cancer. Bladder cancer: diagnosis and management. NICE Guideline. 2015.

SOURCE Natera, Inc.