Exact Sciences says gets warning letter from FDA

LOS ANGELES, Oct 16 (Reuters) - Exact Sciences Corp (EXAS.O: Quote, Profile, Research, Stock Buzz) said on Tuesday it received a warning letter from U.S. regulators regarding its colon cancer screening product.

The Marlborough, Massachusetts, company said that according to the warning letter from the Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety, the FDA believes Exact's PreGen-Plus assay is a medical device requiring pre-market approval or clearance.

"Having spoken with the FDA regarding the letter, we are committed to working collaboratively with them to pursue the appropriate filing strategy for our DNA colorectal cancer screening technology," Jeffrey Luber, Exact's president, said in a statement. (Reporting by Lisa Baertlein)