Officials at Exact Sciences Corp. are preparing to answer tough questions this week from the FDA, which meets to discuss the results of the Madison company’s stool-based test for colon cancer. Thus far, the company’s test has been shown in clinical trials to be effective at detecting tumors and unusual growths, but it has also resulted in less accurate results among certain racial and ethnic groups and has delivered some false positives overall. Results recently released from the company’s 10,000-patient clinical trials found a 6% failure rate.
The FDA wants to know about real-world implications of the non-invasive test and is seeking input as to how best to inform the public about the possibility of inaccurate test results.
Meanwhile, James Connelly, the company’s chairman of the board since 2010, has submitted his resignation and Kevin Conroy, CEO, has been appointed to succeed him in that role. Connelly reportedly left for personal reasons.
