Helene T writes, "I understand you missed seeing Exact Sciences at the BIO meeting last week but I was hoping you had a chance to circle back and get an update. Any thoughts?"
Yes, I spoke with Exact CEO Kevin Conroy on Tuesday. Conroy assured me the company will release updated validation data for its Cologuard colon cancer-screening test at some point this year. He's being purposely coy about timing, in part because he wants to avoid repeating last fall's "sell the news" reaction to the initial Cologuard validation data.
For those who need a refresher of the previous data, Cologuard detected 85% of colon cancers and 64% of early pre-cancers. The pre-cancer sensitivity, in particular, was especially strong, surpassing the company's goal of detecting 50% of pre-cancerous lesions. Patients benefit most when cancer is detected as early as possible, which is why Exact Sciences is engineering Cologuard to be especially sensitive to pre-cancerous lesions in the colon. Existing colon-cancer screening tests don't do a good job of picking up early-stage cancer.Exact Sciences is working on improving Cologuard's performance and reaching final agreement with the Food and Drug Administration on a phase III study design. "I'm very happy with the way we came out of last year, especially achieving our goals for cancer and pre-cancer sensitivity," said Conroy. "We're tuning the assay to make it more specific and sensitive, and I'd say we're about 80% of the way through these enhancements and should be finished in the near term." Conroy says Exact Sciences is on track to start the phase III study in the third quarter, as previously forecast. The study intends to enroll between 8,600 and 12,000 patients who are at average risk for colon cancer. Enrolling average-risk patients (as opposed to only high-risk patients, for example) sets a higher performance bar for Cologuard, but it will also yield the strongest and most "real world" assessment of the test's performance. With these data, Exact Sciences can make a very compelling case for higher pricing and more comprehensive insurance coverage -- all of which translates into (hopefully) higher Cologuard peak sales down the road. Exact Sciences' biggest enemies today are time and a lack of short-term catalysts to get attention-addled investors interested in the stock right now. The phase III study won't begin until the spring and will take about 12 months to fully enroll, which means we won't see results until the back end of 2012.
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