Medicare Issues Draft Local Coverage Determination for Signatera™

Medicare Issues Draft Local Coverage Determination for Signatera™ in Immunotherapy Response Monitoring. Proposes expanded coverage of the Signatera minimal residual disease (MRD) test in a broad range of solid tumor types and indications including immunotherapy (IO) monitoring.

Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the CMS Molecular Diagnostics Program (MOLDX) has issued a draft local coverage determination (LCD) to provide expanded coverage for circulating tumor DNA (ctDNA) tests that detect MRD in patients with a history of cancer. In particular, the proposed expansion would cover the Signatera MRD test for immunotherapy response monitoring. The LCD is posted here on the Centers for Medicare and Medicaid Services website.

The proposed LCD follows Medicare’s recent final coverage decision in colorectal cancer released earlier this month. In its description of the IO monitoring indication, the draft LCD specifically references Signatera and the pan-cancer validation study recently published in Nature Cancer.1 In that study, Signatera identified treatment non-responders with a 100% positive predictive value, when used in conjunction with imaging.

In addition, the draft LCD creates a pathway for coverage of Signatera in additional solid tumor types and indications, where it is clinically validated with peer-reviewed evidence and where the clinical utility is established. Signatera has been validated across multiple cancer types to detect residual disease up to 2 years earlier than standard diagnostic tools.2-5

“Medicare’s proposed coverage offers enormous benefit to the over 200,000 patients being treated with immune checkpoint inhibitors,6” said Solomon Moshkevich, General Manager of Oncology at Natera. “We look forward to working with the oncology community to generate further evidence supporting the clinical value of Signatera in both early-stage and advanced-stage cancers.”

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 clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. 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 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. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera 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 pioneer and global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn

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 our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations regarding the reliability, accuracy and performance of our screening tests, or regarding the benefits of our screening 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, [email protected]

References

  1. Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020.
  2. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131. 
  3. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-426. 
  4. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451. 
  5. Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019; 37(18):1547-1557.
  6. IQVIA™ Institute for Human Data Science Releases Global Oncology Trends 2019 Study: Record Number of Cancer Drugs Launched in 2018 across 17 Indications. IQVIA. https://www.iqvia.com/newsroom/2019/05/iqvia-institute-for-human-data-science-releases-global-oncology-trends-2019-study-record-number-of-c. Published 2019.


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