Exact Sciences wins FDA approval and more for next-gen colon cancer test

Exact Sciences ($EXAS) gained FDA premarket approval for its new, cutting-edge colorectal cancer screening test. It is also well ahead in the insurance reimbursement battle. The Wisconsin molecular diagnostics company already has a coverage recommendation from the Centers for Medicare and Medicaid Services (CMS), thanks to its participation in a joint pilot program involving both agencies dubbed "parallel review."

Exact Sciences CEO Kevin Conroy

Exact's Cologuard represents a big step forward in the standard of care. It's the first FDA-approved noninvasive stool DNA screening test for colorectal cancer. Colon cancer diagnosis typically involves less sophisticated fecal blood tests or more invasive colonoscopies and biopsies. Cologuard analyzes stool DNA and blood biomarkers, and can spot 92% of cancers and 69% of the most advanced precancerous polyps in typical patients, the company said.

"The FDA approval of Cologuard represents a major achievement in Exact Sciences' mission to make a noninvasive, patient-friendly screening test for colorectal cancer available," Exact Sciences President, CEO and Chairman Kevin Conroy said in a statement.

Cologuard's approval comes after a clinical trial that screened more than 10,000 patients. The test soared at cancer or polyp detection. But the FDA, in its approval announcement, noted that it was less accurate than the typically used fecal immunochemical test (which detects blood in the stool) in identifying subjects that are negative for colorectal cancer or advanced adenomas. Regulators were also quick to point out that the test doesn't change existing standards for colorectal cancer screening, which do not include stool DNA testing as a recommended diagnostic tool. Patients ages 50 to 75 at average risk for colon cancer are recommended to use the typical fecal blood test, sigmoidoscopy or colonoscopy, according to guidelines by the U.S. Preventive Services Task Force reiterated by the FDA.

In conjunction with the FDA approval, CMS issued a proposed national coverage determination for Cologuard, the first product to go through the FDA/CMS pilot program designed to reduce the time between the FDA's approval of a device and the obtaining of Medicare coverage. Exact's decision to pursue this turned out to be a smart one, considering that diagnostics companies have a much harder time these days obtaining both federal and private insurance reimbursement for new tests in a timely fashion. The FDA, in its announcement, said the parallel review process, which enabled each agency to review the test at the same time, probably cut several months off the typical review timeline.

CMS proposes to approve Medicare coverage for Cologuard once every three years for patients who are between ages 50 and 85, are asymptomatic, and at average risk of developing colorectal cancer. Private insurers typically follow CMS' lead.

"The pilot program is ongoing, but we will apply what we have learned to improve the efficiency of the medical device approval pathway for devices that address an important public need," Nancy Stade, deputy director for policy at the Center for Devices and Radiological Health, said in a statement.

Meanwhile, Exact Sciences said it will offer the test through healthcare providers in the U.S. for $599. Plans are underway to make the test available in some European countries, once a CE marking is obtained.

Exact won unanimous FDA panel approval for its test in late March and raised nearly $120 million in early April through a stock offering. The money was targeted to fund the final regulatory approval process and Cologuard's commercial launch.

- read the company announcement
- here's the FDA's release