UPDATE 1-Exact Sciences says gets warning letter from FDA

(Recasts, adds timing of FDA meeting, details, byline)

By Lisa Baertlein

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, who believe the company's noninvasive colon cancer screening test requires regulatory approval.

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

The test is already being sold to U.S. physicians and patients.

"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.

The company said a potential regulatory filing had already been part of its long-term strategy for PreGen-Plus.

Luber did not immediately return a call requesting further comment.

Exact is scheduled to meet with the FDA in the coming weeks and intends to file an application with the FDA as soon as possible to resolve the issues, the company said.