CMS declines to reimburse for 1st FDA-approved blood-based CRC screening test 

Eric Oliver - Print  |

The FDA declined to extend National Coverage Determination to Epigenomics AG for its Epi proColon, a blood-based colorectal cancer screening test, the company announced Jan. 21.

Epigenomics AG will challenge CMS' decision by either appealing or bringing some form of litigation. 

In October 2020, CMS created a guideline for blood-based tests to earn NCD approval. In its most recent decision, CMS eliminated a condition that would require the test to be recommended by a professional society guideline, consensus statement or U.S. Preventive Services Task Force recommendation, according to a SeekingAlpha report.

CMS did retain a portion of the guideline that relates to sensitivity and specificity. CMS will only cover a test with a sensitivity of at least 74 percent and a specificity of at least 90 percent. 

Greg Hamilton, Epigenomics AG CEO, previously took issue with this portion of the guideline. He said in a release, "Randomly selecting sensitivity, specificity and testing interval values from various tests and assuming it will reduce CRC Mortality is not the appropriate way to make evidence-based care decisions." 

Many people view the guideline as favoring in-development tests by Exact Sciences and Guardant Health. On the news of CMS' decision, stocks for both companies increased 1.6 percent and 1.1 percent, respectively, SeekingAlpha reports.

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