While I was in Galway, Ireland, last week to attend the Irish Medical Technology Industry Excellence Awards, I had the opportunity to speak with Kevin Conroy, President and CEO of Exact Sciences (Madison, WI). His company has developed a stool DNA colorectal cancer screening test, the first module of which was submitted to FDA for premarket approval on December 7, 2012.
Conroy was invited to address the CEO Forum, an all-day meeting on December 13 held prior to the gala dinner and awards in the evening. The pesky press is not allowed into that meeting, and participants are characteristically tight-lipped about what is discussed, but Conroy did mention that he shared insights on raising capital with his Irish colleagues. It's clearly a subject he knows well, as his company has raised $175 million over the past 3 1/2 years. It's a big vote of confidence in the company's noninvasive, molecular screening technology for the detection of colorectal cancer.
"Our technology is unique in that it is a patient-friendly preventive test that detects precancer," says Conroy. "The only other noninvasive screening method for colorectal cancer is the fecal blood test, but it won't find precancers."
Exact Sciences' test identifies DNA that originates from cancers and precancers in stool samples. Patients use Exact Sciences’ test to collect a stool sample at home and send it to a clinical laboratory. Using Exact Sciences’ process, the laboratory can isolate the human DNA and identify specific altered and mutated DNA targets, known to be associated with colorectal cancer and precancer, and report the findings.
If all goes well, the company plans to have everything submitted to FDA for a PMA by May 2013; a CE mark is expected in 2013, as well. "We are looking at other markets for 2014," adds Conroy, "possibly as soon as next year."