Exact Sciences Corp. CEO Kevin Conroy said he doesn’t think the launch of a competing product on Monday will put much of a dent in sales of Cologuard, the Madison company’s stool-based DNA test for colorectal cancer.
Laboratory Corp. of America (LabCorp) said it will offer Epi proColon, a blood test for colorectal cancer screening developed by the German company Epigenomics.
LabCorp — parent company of Covance, one of Madison’s largest private employers with nearly 2,000 employees here — is one of the world’s biggest health care diagnostics companies.
It is the first U.S. lab to offer Epi proColon since the U.S. Food and Drug Administration approved it in April.
Conroy told a conference call with analysts last week, though, he does not expect Epi proColon to have “a significant impact in the market.”
For one thing, its accuracy in clearing people without cancer is 79 percent.
“That means one out of five people who get the test have a false positive and go on to colonoscopy,” Conroy said.
Cologuard was 90 percent accurate in identifying those without colorectal cancer in a study of 10,000 people.
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Epigenomics’ test also was less sensitive in recognizing cancer cells, said Jeffrey Elliott, senior analyst with Robert W. Baird & Co.
On top of that, Medicare will not reimburse the cost of Epi proColon at this time and major insurance companies generally wait until that happens, Elliott said.
Cologuard won Medicare coverage at the same time as FDA approval, in fall 2014, and it continues to add private insurance coverage.
Cologuard and Epi proColon went before the FDA at the same time in 2014, and Cologuard was approved while Epi proColon was sent back for further testing.
It has been available through some labs, regardless, “without seeing much success at all,” Elliott said.
“They have a lot of work cut out for them,” Elliott said of Epi proColon.
Exact Sciences said, in its quarterly report last week, it received about 40,000 completed Cologuard tests during the first quarter of 2016 and expects to process more than 240,000 throughout 2016.