MARLBOROUGH, Mass.--(BUSINESS WIRE)--EXACT Sciences Corporation (NASDAQ: EXAS) today announced that it has confirmed with the U.S. Food and Drug Administration (FDA) the clinical performance characteristics and the minimum number of average-risk cancer samples that will be required for validation of its Version 2 stool-based DNA technology for colorectal cancer screening. In order to bolster the statistical power of the clinical study, EXACT intends to accrue more clinical samples than the threshold that the FDA indicated would be acceptable. As a result, the Company believes that the clinical study, as well as the contemporaneous requisite technical studies, will take approximately six to nine months to complete based on expected enrollment rates. This timing would allow for an anticipated de novo 510(k) filing in the third quarter of 2009, and potential clearance or approval of its Version 2 technology in the first quarter of 2010. EXACT estimates that total study and regulatory costs will range from $6.5 to $8.5 million. The Company’s current cash and short term investments provide for approximately $2 million through the end of 2008 to begin the clinical and technical validation studies.
