LabCorp Launches Colorectal Cancer Test, But Key Hurdles Remain

Xconomy Wisconsin — 

The market for colorectal cancer tests that are less cumbersome than colonoscopies is getting more crowded.

LabCorp announced the launch of a blood-based colorectal cancer test on Monday, which will pit it against other makers of non-invasive diagnostics for such diseases, including Madison, WI-based Exact Sciences (NASDAQ: EXAS).

Burlington, NC-based LabCorp (NYSE: LH) has worked to commercialize the test—known as Epi proColon—in North America through a partnership with Germany-based Epigenomics and Polymedco, of Cortlandt, NY. Epigenomics developed the test. Polymedco, meanwhile, supplies clinical diagnostic test kits, and LabCorp performs clinical laboratory tests and related services.

Epi proColon is the first blood-based test for colorectal cancer screening the FDA has approved for clinical use, a decision rendered last month, Epigenomics said.

“Many people are not screened because they are reluctant to collect a stool sample or undergo a colonoscopy,” said Mark Brecher, chief medical officer of LabCorp Diagnostics, in a prepared statement. (Brecher’s statement could be read as a shot at Exact Sciences, whose colorectal cancer test requires patients to collect some of their stool in a container and ship it to the company’s Madison lab.)

The test developed by Epigenomics, on the other hand, works by analyzing a blood sample for a DNA biomarker tied to colorectal cancer, according to clinical studies. The “Septin9 DNA methylation” biomarker is proprietary to Epigenomics, according to a press release.

Jeff Elliott, a senior research analyst at Robert W. Baird & Co., said that while receiving FDA clearance was a key step for Epigenomics’ test, it still has yet to be approved for insurance reimbursement by the Centers for Medicare & Medicaid Services (CMS). That’s something commercial insurers watch closely, he said.

“Medicare is half of the colorectal cancer market,” Elliott said. “Commercial payers like Aetna, UnitedHealth, and Cigna often follow what Medicare does.”

Meanwhile, Exact Sciences got its test, known as Cologuard, approved by CMS and the FDA simultaneously in 2014.

“That gave [Exact Sciences] a several-year head start over what I believe Epigenomics will have to do,” Elliott said. “The Medicare process is quite lengthy.”

According to Exact Sciences company materials, Cologuard’s sensitivity across all stages of colorectal cancer is 92 percent, compared with 68 percent for Epi proColon.

A LabCorp spokeswoman could not be reached for comment.

Exact Sciences is now seeking to ramp up its sales and more aggressively market Cologuard to physicians and patients, in part through a national TV advertising campaign.