AU.S. Food and Drug Administration (FDA) panel has unanimously recommended Exact Sciences Corp.’s colorectal cancer screening assay be approved for use in the United States, concluding it had demonstrated its safety and effectiveness while demonstrating a favorable risk-benefit profile. The test, known as Cologuard, can detect colorectal cancer through a stool sample. Current screening methods for patients with an average risk for contracting the disease include physical and virtual colonoscopies. Both are costly, and the former test is invasive and occasionally painful. Nearly 132,000 Americans were diagnosed with colorectal cancer in the United States in 2010, according to data from the Centers for Disease Control and Prevention. More than 52,000 died from the disease in 2010. Five-year survival rates are far higher when the disease is caught in its early states than in the middle or later stages. That has led to clinical guidelines suggesting that those over the age of 50 undergo stool testing for colorectal cancer annually if they have an average risk for contracting the disease and more invasive screenings every five to 10 years. The FDA’s molecular and clinical genetics panel of the medical devices advisory committee recommended the test for use. The agency is not […]
AU.S. Food and Drug Administration (FDA) panel has unanimously recommended Exact Sciences Corp.’s colorectal cancer screening assay be approved for use in the United States, concluding it had demonstrated its safety and effectiveness while demonstrating a favorable risk-benefit profile.
The test, known as Cologuard, can detect colorectal cancer through a stool sample. Current screening methods for patients with an average risk for contracting the disease include physical and virtual colonoscopies. Both are costly, and the former test is invasive and occasionally painful.
Nearly 132,000 Americans were diagnosed with colorectal cancer in the United States in 2010, according to data from the Centers for Disease Control and Prevention. More than 52,000 died from the disease in 2010. Five-year survival rates are far higher when the disease is caught in its early states than in the middle or later stages. That has led to clinical guidelines suggesting that those over the age of 50 undergo stool testing for colorectal cancer annually if they have an average risk for contracting the disease and more invasive screenings every five to 10 years.
The FDA’s molecular and clinical genetics panel of the medical devices advisory committee recommended the test for use. The agency is not bound to follow the recommendation, but such guidance is key to obtaining full regulatory approval for marketing the test in the United States.
“We are pleased the committee strongly supported Cologuard’s approval,” said Kevin T. Conroy, chief executive officer of Exact Sciences, which is based in Madison, Wis. “We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening.”
Exact Sciences has also provided research suggesting that its test is more accurate than the current stool testing, which often requires follow-up examinations. A study of 10,000 patients with average colorectal cancer risk who underwent the Cologuard test accurately diagnosed cancer 92.3 percent of the time. The study’s findings are being published in the most current issue of the New England Journal of Medicine.
Takeaway: Exact Sciences’ noninvasive colorectal cancer test is inching toward being offered in the U.S. market.
