03.31.14
The U.S. Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has voted unanimously that Exact Science’s Cologuard stool-based DNA test is safe, effective, and has a favorable risk benefit profile.
“We are pleased the committee strongly supported Cologuard’s approval,” said Kevin T. Conroy, chairman and CEO of Exact Sciences. “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. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program.”
In the company’s 10,000-patient, 90-site DeeP-C pivotal trial, Cologuard found 92.3 percent of colorectal cancer in average-risk patients based on a combination of DNA and hemoglobin markers. Exact Sciences submitted the final module of its PMA for Cologuard on June 7 last year and the application includes data from that study, which was published online on March 19, 2014, in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening,” will also appear in the journal’s April 3 print issue.
Exact Sciences is now hoping for pre-market approval from the FDA for Cologuard. A committee’s favorable response is not a guarantee for device approval, but the agency usually follows advisory committee recommendations.
Madison, Wis.-based Exact Science is a molecular diagnostics company focused on colorectal cancer.
“We are pleased the committee strongly supported Cologuard’s approval,” said Kevin T. Conroy, chairman and CEO of Exact Sciences. “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. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program.”
In the company’s 10,000-patient, 90-site DeeP-C pivotal trial, Cologuard found 92.3 percent of colorectal cancer in average-risk patients based on a combination of DNA and hemoglobin markers. Exact Sciences submitted the final module of its PMA for Cologuard on June 7 last year and the application includes data from that study, which was published online on March 19, 2014, in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening,” will also appear in the journal’s April 3 print issue.
Exact Sciences is now hoping for pre-market approval from the FDA for Cologuard. A committee’s favorable response is not a guarantee for device approval, but the agency usually follows advisory committee recommendations.
Madison, Wis.-based Exact Science is a molecular diagnostics company focused on colorectal cancer.