CMS Colon Cancer Screening Memo Bodes Well for Assays in Development; Denies Epi ProColon

The US Centers for Medicare and Medicaid Services released a draft decision memo on Friday describing criteria for the coverage of current and future blood-based colorectal cancer screening tests.

The agency also wrote that it would provide coverage for blood-based biomarker tests — if and when they receive US Food and Drug Administration market authorization — for asymptomatic CRC screening once every three years or at another interval designated by the US Food and Drug Administration.

The agency described several requirements that must be met by such tests. These include the patient being age 50 or over, truly asymptomatic, and without known risk factors such as family history of CRC or its precursors.

Tests must also demonstrate both sensitivity greater than or equal to 74 percent and specificity greater than or equal to 90 percent as determined by comparison to the recognized standard, which is currently colonoscopy. Finally, they must either be recommended by the United States Preventive Services Task Force or included in guidelines of at least one professional society or consensus statement.

There has been significant investment in recent years in firms like Freenome, Exact Sciences, Guardant Health, and Grail which are all developing tests that might fall under CMS’s new memo if approved by the FDA in coming years.

Source: https://www.genomeweb.com/business-news/cms-colon-cancer-screening-memo-bodes-well-assays-development-denies-epi-procolon