FDA Clears First Blood-Based Colorectal Cancer Screening Test

Megan Brooks

April 14, 2016

The first blood-based colorectal cancer (CRC) screening test, Epi proColon (Epigenomics AG), has been approved by the US Food and Drug Administration (FDA). It is already available in Europe and some other countries.

The Epi proColon test is a qualitative in vitro diagnostic test for detecting methylated Septin9 DNA, which has been associated with the occurrence of CRC, in plasma obtained from whole-blood specimens. It is indicated for use in average-risk patients who have chosen not to undergo other screening methods, such as colonoscopy or stool-based tests.

The test was recommended for FDA approval in 2014 by the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee, but some of the experts were not convinced, as reported by Medscape Medical News at the time. The panel members were in agreement about whether the test is safe (nine members voted yes, one abstained). Regarding whether or not the test is effective, five panel members voted yes, and six, no. Regarding whether or not its benefits outweigh its risks, five panel members voted yes; four, no; and one abstained.

At the time, several panel members voiced concern about use of the Epi proColon test for screening, especially insofar as the test failed to perform better than the fecal immunochemical test (FIT).

"I'm uncomfortable with not clarifying that it should be an alternative for people who are not willing to take the FIT test," voting panel member Karen E. Weck, MD, professor and director of the Molecular Genetics Laboratory, University of North Carolina, Chapel Hill, said at the time.

The FDA apparently got the message. The agency approved the Epi proColon test for CRC screening in average-risk patients (as defined by current screening guidelines) who choose not to be screened by colonoscopy or a stool-based FIT.

The Epi proColon blood test for CRC screening can be performed during routine office visits. It requires no dietary restrictions or alterations in medication use. The blood sample is analyzed by a local or regional diagnostic laboratory.

The FDA approved the Epi proColon test on the basis of results of three clinical studies and its potential to significantly increase participation rates in CRC screening, the company said.

The company will initiate a postapproval study to show the long-term benefit of blood-based CRC screening using Epi proColon, as required by the FDA.

Epi proColon is currently marketed in Europe, China, and selected other countries.


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