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

NEW YORK – 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 memo, which is currently open for public comment, has implications for a number of companies developing circulating tumor DNA and epigenomic tests in the space, and at least one firm currently marketing a blood-based assay, Epigenomics' Epi proColon.

According to CMS, Epi proColon does not meet its proposed criteria, and thus, based on current evidence, CMS intends not to cover the assay for Medicare-eligible patients.

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.

CMS 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, and Guardant Health, which are all developing tests that might fall under CMS's new memo if approved by the FDA in coming years.

In various research notes, analysts expressed that the criteria described, especially the technical requirements for sensitivity and specificity, appear to be a lower bar than many had expected, and thus bode well for future coverage considering the data that companies have already reported for many of these assays.

The anticipation is that tests that gain approval and coverage might come to displace Exact Sciences' current stool-based screening assay Cologuard.

Puneet Souda of SVB Leerink wrote that the decision memo is a "clear positive" for liquid biopsy companies, with the bar for sensitivity and specificity well within reach, especially for firms currently conducting large-scale registrational CRC screening trials.

"These requirements appear to be achievable given … data presented by Guardant and Freenome so far that are well ahead of those performance metrics. Though we expect the performance of these tests to deteriorate slightly in the large-scale registrational trials, we can see these … tests meeting the sensitivity and specificity bar for obtaining a national coverage determination," Souda wrote.

Meanwhile, BTIG's Mark Massaro argued that it's too early to draw conclusions about the future competitive landscape considering the multiple variables at stake, but at first glance, he said, "it appears that CMS may be more willing to cover a less sensitive test [than Cologuard] in favor of the added convenience … of a simple blood test."