AUSTIN, Texas, Nov. 11, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing, today announced that the CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease (MRD) test. An accompanying Billing and Coding Article, linked here, specifies that serial testing with Signatera is now covered for Medicare patients being treated with immunotherapy, regardless of tumor type. The final LCD is consistent with the draft posted in September 2020, also establishing an accelerated pathway to Signatera coverage in new testing indications.
Over 200,000 patients per year are treated with immunotherapy.1 Studies show that only 20-30% of patients respond positively to immunotherapy, yet many patients remain on treatment for much longer than necessary, due to unreliable methods for evaluating disease progression.2 In particular, radiographic imaging is unable to differentiate between true disease progression and pseudo-progression. Results from the INSPIRE study, published recently in Nature Cancer, reported that personalized ctDNA monitoring with Signatera can identify treatment non-responders with 100% positive predictive value, just 6 weeks into treatment, when used in conjunction with imaging.
"Monitoring ctDNA kinetics with Signatera can identify treatment non-responders earlier than imaging alone, and independent of other biomarkers including PD-L1 and tumor mutational burden (TMB)," said Solomon Moshkevich, general manager of oncology for Natera. "We look forward to working with Medicare and with the oncology community, to make personalized monitoring and MRD assessment accessible for cancer patients of all tumor types."
The final LCD for immunotherapy monitoring is posted here. This is the second Medicare LCD covering Signatera (the first was in early-stage CRC, found here); but it is the first covering Signatera for pan-cancer use, in any patient where immunotherapy is indicated.
About Signatera 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 quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
Natera™ is a leader in personalized genetic testing and diagnostics, transforming how we make critical health care decisions. Our tests help clinicians and their patients protect their health and enable earlier and more targeted interventions that lead to better outcomes. Natera’s tests are validated by more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women’s health and organ health. 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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our 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 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 atwww.natera.com/investors andwww.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090 Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]