LabCorp launches first FDA-approved blood-based colon cancer test with Epi proColon 

Laboratory Corporation of America on Monday announced the launch of Epi proColon, the first blood-based test for colorectal cancer screening in the US, where it was approved for clinical use last month. LabCorp said the test, which was developed by Epigenomics and is available under a joint commercialisation agreement with Polymedco in North America, "offers an alternative for patients non-compliant with existing screening options." 

According to LabCorp, the Epi proColon test is designed to detect Epigenomics' proprietary Septin9 DNA methylation biomarker for colorectal cancer in cell-free DNA circulating in blood. The company noted that the biomarker "has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer."

Mark Brecher, chief medical officer at LabCorp, said "colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically," adding that "tested from a simple blood draw, Epi proColon is a convenient, accurate alternative for those patients who should be screened for colorectal cancer." 

Commenting on the news, Robert W. Baird & Co. analyst Jeff Elliott noted that while FDA approval was a critical step, Epi proColon has yet to receive authorisation for insurance coverage by the US Centers for Medicare & Medicaid Services (CMS). "Medicare is half of the colorectal cancer market," explained Elliott, adding that "commercial payers like Aetna, UnitedHealth and Cigna often follow what Medicare does." 

The analyst pointed out that Exact Sciences' non-invasive stool-based colorectal cancer test Cologuard had been granted near simultaneous approval by the FDA and CMS in 2014. "That gave [Exact Sciences] a several-year head start over what I believe Epigenomics will have to do," Elliott said, adding "the Medicare process is quite lengthy." 

Meanwhile, Exact Sciences said in a corporate presentation this month that Cologuard's sensitivity across all stages of colon cancer is 92 percent, compared with 68 percent for Epi proColon. The company also revealed alongside its first-quarter results that it recently completed an advertising campaign during which it saw an average "50-percentage point increase in Cologuard orders and a 100-percentage point increase in new ordering physicians in the test markets versus control markets."