NEW YORK (GenomeWeb News) – Exact Sciences has finished the construction of its internal laboratory and received CLIA certification for it in the fourth quarter, the company said on its fourth quarter earnings conference call on Thursday.
The firm also is in the process of securing licenses to offer its tests in those states that require separate licensure, Exact Sciences COO Maneesh Arora said on the call.
The Madison, Wis.-based firm built the lab in anticipation of a positive decision by the US Food and Drug Administration on its premarket approval submission for its Cologuard colorectal cancer test. The company is scheduled to meet with FDA next week on its submission.
Exact Sciences also said that it has chosen Quintiles as a contract sales organization to help promote Cologuard when it launches. Quintiles' sales representatives will be "dedicated to us and our efforts," Arora said.
Upon the launch of the test, Exact Sciences will have a commercial team of about 100 people, comprised of 50 Quintiles sales reps, 25 Exact Sciences sales reps, and 25 who will be involved in other parts of the commercial operations, including marketing, Exact Sciences President and CEO Kevin Conroy said.
The company reported flat revenues year over year for its fourth quarter.