FDA Decision Expands Market for Exact Sciences’ Cologuard Test
Summary
Cologuard received clearance from the FDA and the Centers for Medicare and Medicaid Services in 2014, and about 3 million patients have been screened with the test to date, according to Exact. One reason is that it’s both diagnostic and therapeutic; healthcare providers find potentially cancerous or pre-cancerous polyps during a procedure, remove them, and send them to a lab for further analysis. Baird analysts Catherine Ramsey Schulte and Thomas Peterson write in their note that they believe the FDA’s decision “will be important in educating physicians about the rising incidence in this age group and Cologuard’s value proposition/ability to increase screening.” In order to get more patients ages 45 to 49 screened for colorectal cancer, a key step is ensuring their primary care providers and other physicians know about the recent changes to the ACS guidelines, Anjee Davis, president of the advocacy group Fight Colorectal Cancer, says in a news release. “Expanding the screening age to 45 for Cologuard provides an additional tool to reach the unscreened populations.” Exact has been growing at a rapid clip since Kevin Conroy took the top job at the company a decade ago. In July, Exact said it was acquiring Genomic Health, a California-based developer of diagnostic tests that analyze gene activity in tumor tissue samples from cancer patients, in a $2.8 billion cash-and-stock deal.
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