Exact Sciences Corp. won U.S. regulatory approval to sell the first noninvasive DNA screening test for colorectal cancer that patients can use at home.
The Food and Drug Administration cleared Cologuard, which screens stool samples for the presence of red blood cells and DNA mutations that may indicate the presence of cancer. Patients use Madison, Wisconsin-based Exact Sciences’ test at home and those who have positive results are advised to get a colonoscopy, which uses a small video camera on the end of a thin tube to view the colon, the FDA said in a statement.
Colorectal cancer primarily affects people ages 50 and older and is the third-most-common cancer in the U.S. Patients must obtain a prescription for the test and can either take it home from their physician’s office or have it mailed to them, Jennifer Haliski, a spokeswoman for the FDA, said in an e-mail.
“This approval offers patients and physicians another option to screen for colorectal cancer,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said yesterday in the statement.
Exact Sciences rose 2.2 percent to $17.46 at the close in New York, and has gained 33 percent in the past 12 months.
The test is also the first to go through a parallel review by the FDA and the Centers for Medicare and Medicaid Services, which makes determinations on whether to cover the cost of products for the U.S. health program for the elderly and disabled. CMS plans to cover Cologuard once every three years for Medicare beneficiaries who are 50 to 85, don’t show symptoms of colorectal cancer and who carry an average risk of developing the cancer.
“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” Nancy Stade, CDRH’s deputy director for policy, said in the FDA statement.
Cologuard’s stool DNA testing isn’t recommended as a method to screen for colorectal cancer by the U.S. Preventive Services Task Force, the FDA said.
In a study, Cologuard detected 92 percent of cancers and 42 percent of advanced precancerous growths, significantly more than an older test that looks only for blood in the stool. False positives occurred in more patients, about 13 percent, with Cologuard, leading them to undergo a colonoscopy that turned up no signs of cancer.