|Exact Sciences CEO Kevin Conroy|
Exact Sciences ($EXAS) has completed its three-step process to win FDA approval for a stool-based cancer diagnostic, submitting the same data that spooked investors back in April with hopes of convincing the agency.
Cologuard, the company's colorectal cancer screening test, is now in the FDA's hands, as Exact has turned in the results from DeeP-C, a pivotal 10,000-patient trial.
The study found 92% colon cancer sensitivity for Cologuard but reported just 42% sensitivity to precancerous polyps and 66% for polyps two centimeters in size or larger, results that sent Exact's shares into a tailspin on their April 17 announcement, dropping as much as 30% in 24 hours.
Since then, however, Exact has slowly inched its stock price upward, trading at around $13 on Monday morning, a nearly 60% increase over April's doldrums.
Now, with the third and final module of its PMA submission complete, Exact plans to work with the agency through final review and build out its commercial operations in preparation for Cologuard's launch, CEO Kevin Conroy said.
"The completion of our PMA submission to the FDA is the most significant milestone in the company's history and a big step forward in helping physicians make the battle against colorectal cancer a winning one," Conroy said in a statement.
The modular PMA process is designed to speed things along for med tech companies, allowing them to get incremental agency feedback, but whether it'll help Exact cash in quickly on Cologuard remains to be seen.
Exact has been stockpiling cash to hit the ground running if Cologuard wins approval, Conroy said, and the company raised about $57.8 million when it went public in August, riding shareholder excitement over the test's potential to outperform colonoscopy.
- read the statement