In a unanimous 10-0 decision late last week, the Food and Drug Administration’s molecular and clinical genetics panel unanimously approved Exact Sciences’ non-invasive, stool-based colorectal cancer test, known as Cologuard, putting it on track toward potential market approval.
Approval followed an FDA/Centers for Medicare & Medicaid Services parallel review program involving several other tests that were submitted for review.
Kevin Conroy, chairman and chief executive of Exact Sciences, believes a successful launch of Cologuard could have the same impact on colorectal cancer that the Pap smear has had on the early detection of cervical cancer. In the United States, both the incidence rates and death rates of cervical cancer have been dramatically reduced over the past several decades.
“We believe with regular programmatic colon cancer screening, colon cancer, like cervical cancer, could be virtually eradicated in the U.S.,” Conroy stated. “Research shows that patients who are given a choice of screening tests are more likely to comply with screening.”
After a recent study showed that Cologuard detected 92.3% of colorectal cancer in average-risk patients and 42% of advanced precancerous lesions, The New England Journal of Medicine published an online report last week claiming the test, which requires patients to submit a stool sample, was found to detect early-stage colorectal cancer better than other noninvasive approaches.
Colorectal cancer remains one of the most common and deadliest forms of cancer in the United States, but it’s considered completely preventable. According to the American Cancer Society, more than 100,000 cases of colon cancer and over 40,000 cases of rectal cancer are diagnosed each year. It’s the second-leading cause of cancer death in the country after lung cancer.
Much of the human toll of colorectal cancer is attributed to the lack of screening options, as many patients still refuse a colonoscopy because of the discomfort and inconvenience involved. Exact Sciences is hopeful that pending approval of the FDA, the addition of Cologuard to the menu of available tests could encourage more people to be screened. The company recently launched the “Be Seen, Get Screened” campaign, which is aimed at raising awareness about the importance of getting screened for colon cancer.
On guard
The FDA is not bound by the recommendation of its advisory committee, but it will consider the committee’s guidance as it evaluates the Cologuard premarket approval application. The panel’s vote indicates that it believes the benefits of the test outweigh the risks.
If Cologuard were approved, patients receiving positive results from the test would be asked to undergo a colonoscopy.
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Market approval for this product line would improve Exact Science’s financial fortunes and justify investors’ faith in the company. Exact Sciences has reported a series of quarterly losses, typically in the millions, but the potential U.S. market for a colorectal screening test has been pegged at $1.2 billion, and Conroy has said the potential global market could reach $3 billion.
Exact Sciences already is engaged in another study, a non-FDA review called OCEANIA, at 15 sites around the country, including sites in Madison and Milwaukee. The study is designed to establish the performance of a stool DNA screening test for colon cancer in patients with inflammatory bowel disease, or IBD.
Conroy noted that IBD patients are at a higher risk for developing colon cancer and as a result begin colon cancer screening at a younger age and with greater frequency. “We believe a non-invasive screening test could be of benefit to both IBD patients and the gastroenterologists who treat them,” Conroy stated.
Exact Sciences’ Madison-based R&D team, in conjunction with partners at the Mayo Clinic, also is looking for ways that stool DNA could be used to detect other gastrointestinal cancers.
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