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.