Natera Receives Final Medicare Coverage for its Signatera™ MRD Test in Stage II-III Colorectal Cancer

SAN CARLOS, Calif., Sept. 3, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the CMS Molecular Diagnostics Program (MOLDX) has finalized a local coverage determination (LCD) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with stage II or III colorectal cancer (CRC). The final LCD is posted here and the billing and coding article here on the Centers for Medicare and Medicaid Services website.

The final LCD is consistent with Medicare’s draft posted in August of 2019, covering two intended uses: (1) Patient risk stratification after surgical resection, to inform adjuvant treatment decisions, and (2) Recurrence monitoring with the same frequency as CEA, in patients with a previous cancer diagnosis but no ongoing evidence of disease. The LCD cites several published studies in its summary of evidence including one study showing Signatera’s ability to detect CRC recurrence up to 16.5 months earlier than imaging and CEA (average 8.7 months earlier).¹

"Colorectal cancer remains one of the deadliest forms of cancer, but it’s also relatively unique as a disease where early detection of relapse is known to improve outcomes," said Scott Kopetz, MD, PhD, oncologist and professor, Department of Gastrointestinal (GI) Medical Oncology, The University of Texas MD Anderson Cancer Center, and Principal Investigator of Natera’s BESPOKE CRC study. "There is ample evidence suggesting that circulating tumor DNA will enable earlier relapse detection and improved decision-making in the adjuvant setting, and I look forward to seeing it used more in clinical practice."

Signatera has been validated across multiple cancer types to detect residual disease up to 2 years earlier than standard diagnostic tools, with virtually no false positives on a per sample level,^1-4  and to help assess treatment response in conjunction with imaging.⁵ While a negative test result does not mean someone is definitely cancer-free, it does mean the risks of relapse or disease progression are significantly reduced.

"Medicare coverage marks a significant milestone in our mission to transform cancer care," said Solomon Moshkevich, General Manager of Natera’s oncology business. "This is the first covered indication for Signatera, with more in process as we continue to publish peer-reviewed studies supporting the validity of personalized ctDNA testing for treatment response monitoring and MRD assessment in multiple solid cancers."

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. 

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.

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, pr@natera.com

References:

1. 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. 
2. 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. 
3. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451. 
4. 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.
5. 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.

SOURCE Natera, Inc.