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Colon cancer blood test post approval study begins

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Epigenomics announced it has begun a post approval study of the blood-based Epi proColon colorectal cancer screening test.

The FDA approved the test in April 2016 for screening patients unwilling or unable to be screened by colonoscopy or take-home stool tests, and it is currently marketed in the U.S., Europe, China and certain other countries, according to a press release.

“The Epi proColon test is a qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens,” according to a product brochure on the company’s website. “Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC). The test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for the methylation specific detection of the Septin 9 DNA target.”

Epigenomics will conduct the Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT) trial in collaboration with the FDA, and will evaluate the test’s participation and performance among 4,500 individuals over the next 3 years. It will also evaluate the willingness of patients with a positive result to undergo colonoscopy.

The multicenter trial will be recruiting at Beaumont Hospital in Royal Oak, Mich., Geisinger Clinic in Danville, Penn., West Virginia University in Morgantown, and three other locations in the U.S. The company expects the study to complete in 2022.

“Epi proColon meets a critical clinical need in the colorectal cancer screening landscape,” Greg Hamilton, CEO of Epigenomics, said in the press release. “One in three Americans are still unscreened despite awareness campaigns and sophisticated patient navigation systems. A blood test addresses the typical patient barriers associated with colonoscopy and stool tests.

This trial will be instrumental in defining the longer-term acceptance and performance of Epi proColon. We are confident that the results will further demonstrate the value of Epi proColon in reaching the millions of eligible Americans that have not yet been screened.” – by Adam Leitenberger

Reference:

Epigenomics: Epi proColon brochure. Accessed August 30, 2017. http://www.epiprocolon.com/wp-content/uploads/sites/3/2017/06/MKT_0026_Physician_messaging_and_brochure_rev5.pdf.

Disclosures: Hamilton is employed by Epigenomics.