Originally published June 24.
Following the submission of its last data module for the Cologuard test with the US Food and Drug Administration, Exact Sciences announced this week that it had raised more than $73 million in net proceeds from a public offering of its common stock.
Exact Sciences said in a statement that the funds give the company working capital that might go toward product development and commercialization activities, and be used to garner FDA approval for Cologuard.
Exact has taken the parallel review pathway to simultaneously seek FDA approval and Medicare coverage for its stool-based DNA colorectal cancer screening tests. On June 7, the company submitted the last of three data modules for its pre-market approval application with the FDA for Cologuard. Exact will submit the necessary data on the test to the Centers for Medicare & Medicaid Services in the fourth quarter of this year (PGx Reporter 4/24/2013).
In the fall, an FDA advisory panel is slated to review data from the pivotal DeeP-C trial, which under the parallel review framework sought answers to questions about the test that were of importance to both the FDA and CMS.
The DeeP-C trial involved 10,000 patients at 90 sites between the ages of 50 and 84 who were at average risk for colorectal cancer, and compared the ability of the genetic test to detect colorectal cancer and pre-cancerous polyps against colonoscopy, the standard of care. Exact will publish the complete data analysis from this study and present it at upcoming medical conferences.
The company expects to hear from the FDA about the Cologuard PMA early next year, and CMS will likely issue its coverage determination around the same time.
According to the data released so far, Cologuard was able to detect cancer with 92 percent sensitivity, detect pre-cancerous polyps that were 1 cm or larger with 42 percent sensitivity, and detect pre-cancerous polyps that were 2 cm or larger with 66 percent sensitivity. The test demonstrated specificity – the ability to detect patients who, following colonoscopy and histopathological analysis, were found to not have cancer or pre-cancerous polyps – of 87 percent.
The secondary endpoints in DeeP-C looked at whether Cologuard was non-inferior and superior to fecal immunochemical testing, a non-invasive method, in different settings. Exact CEO Kevin Conroy has previously noted that in DeeP-C Cologuard met these endpoints, but has not provided specific numbers.
Having now completed its regulatory submissions package to the FDA, however, Exact is focusing on submitting the necessary data to CMS, preparing to have DeeP-C data reviewed before an expert panel, and ultimately launching the test commercially next year. The money raised via public offering of its common stock should help fund these additional activities. In selling 6,325,000 shares at $12.35 per share, Exact brought in $78 million in gross proceeds.
Exact recently announced it was building its commercialization team for Cologuard and is looking to hire a senior financial officer. Once the test is available on the market, Maneesh Arora will be in charge of US sales and marketing activities related to Cologuard.