FDA believes that the PreGen-Plus assay is a medical device requiring pre-market approval or clearance.
Jeffrey Luber, president of Exact Sciences, commented: “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.
“We have a meeting scheduled with the FDA in the coming weeks and intend to file a 510(k) application with the FDA as soon as possible to resolve these issues. A potential regulatory filing for our patent-protected technology had already been a long-term strategy for EXACT and we will now be accelerating these activities.”