Less than two weeks after Madison, Wis.-based Exact Sciences Corp. received federal approval of its molecular test to detect colon cancer, the first major health care provider moved to include it in its coverage. The Rochester, Minn.-based Mayo Clinic, which operates hospitals and outpatient care centers in Minnesota, Arizona, and Florida, said on Aug. 25 it would make the Cologuard assay available via its network of primary care physicians. “Cologuard represents a significant advancement in identifying colorectal cancer at its most treatable stage. We believe offering this new tool will promote patient and community public health and may move more patients to get screened earlier,” said Vijay Shah, M.D., chair of Mayo Clinic’s gastroenterology and hepatology departments. The approval by Mayo came just 13 days after the Food and Drug Administration and the Centers for Medicare and Medicaid Services approved the test for use and for coverage as part of a pilot program to conduct parallel reviews of some laboratory tests. The stool-based test kit is able to detect DNA abnormalities and biomarkers in trace amounts of blood that may be shed by precancerous intestinal polyps. Exact Sciences claims the test can detect more than 90 percent of colon cancers […]
Less than two weeks after Madison, Wis.-based Exact Sciences Corp. received federal approval of its molecular test to detect colon cancer, the first major health care provider moved to include it in its coverage.
The Rochester, Minn.-based Mayo Clinic, which operates hospitals and outpatient care centers in Minnesota, Arizona, and Florida, said on Aug. 25 it would make the Cologuard assay available via its network of primary care physicians.
“Cologuard represents a significant advancement in identifying colorectal cancer at its most treatable stage. We believe offering this new tool will promote patient and community public health and may move more patients to get screened earlier,” said Vijay Shah, M.D., chair of Mayo Clinic’s gastroenterology and hepatology departments.
The approval by Mayo came just 13 days after the Food and Drug Administration and the Centers for Medicare and Medicaid Services approved the test for use and for coverage as part of a pilot program to conduct parallel reviews of some laboratory tests.
The stool-based test kit is able to detect DNA abnormalities and biomarkers in trace amounts of blood that may be shed by precancerous intestinal polyps. Exact Sciences claims the test can detect more than 90 percent of colon cancers and nearly 70 percent of advanced precancerous polyps in patients who are considered to be at average risk of contracting the disease.
Exact Sciences has positioned the assay—which retails for $599—as a less expensive and far less invasive alternative to a colonoscopy, which can cost $2,000 or more. As a result, company officials expect the estimated 23 million Americans over the age of 50 who haven’t been screened for colon cancer will shrink. While the five-year survival rate in the earliest stages of the disease is nearly 75 percent, only about 40 percent of the cases are diagnosed in the earliest stages. The survival rates among those with the more advanced form of the disease are below 30 percent.
Takeaway: A protracted approval process for the Cologuard test is apparently no impediment for its swift adoption by major health care providers.
