Natera’s Signatera MRD Test for CRC Gets Local Coverage Decision from CMS

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Colon cancer. Cancer attacking cell. Colon disease concept

Cell-free DNA testing company Natera, announced Thursday that its Signatera molecular residual disease (MRD) test in patients with stage II or III colorectal cancer (CRC) received a local coverage determination for the Centers for Medicare & Medicaid Services Molecular Diagnostics Program.

“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, M.D., Ph.D., oncologist and professor, 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.”

The final LCD is consistent with Medicare’s draft posted more than a year ago that covered the test for patient risk stratification after surgical resection, to inform adjuvant treatment decisions; and disease recurrence monitoring with the same frequency as carcinoembryonic antigen (CEA) test, in patients with a previous cancer diagnosis but no ongoing evidence of disease. According to one study assessing the efficacy of the test, Signatera was able to detect CRC recurrence up to 16.5 months earlier than imaging and CEA, with an average earlier detection span of 8.7 months.

According to a Natera press release, Signatera has been validated across multiple cancer types to detect residual disease as early as 2 years before standard diagnostic tools, with virtually no false positives on a per sample level, and to help assess treatment response in conjunction with imaging.

“Medicare coverage marks a significant milestone in our mission to transform cancer care,” said Solomon Moshkevich, GM of Natera’s oncology business in a press release. “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.”

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