The FDA has approved stool-based colorectal cancer diagnostic device from Exact Sciences, according to a Medscape report. Here are five things to know about the device.
1. Cologuard is designed to detect colorectal neoplasia and associated DNA markers, as well as the presence of occult hemoglobin. A positive result indicates the presence of colorectal cancer or advanced adenoma. In the case of a positive result, the test is designed to be followed by diagnostic colonoscopy.
2. In May, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Committee unanimously supported FDA approval of the diagnostic device. The panel agreed that the test is effective, safe and benefits outweigh the risks.
3. A large clinical trial comparing Cologuard with fecal immunochemical testing found Cologuard to have superior detection rates. Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas, while FIT detected 72 percent of cancers and 24 percent of advanced adenomas.
4. CMS has also a issued proposed national coverage determination for Cologuard. The diagnostic test is the first product to be pass through the joint FDA-CMS pilot program review process. Proposed CMS coverage would be once every three years for asymptomatic Medicare beneficiaries age 50 to 85 years old.
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1. Cologuard is designed to detect colorectal neoplasia and associated DNA markers, as well as the presence of occult hemoglobin. A positive result indicates the presence of colorectal cancer or advanced adenoma. In the case of a positive result, the test is designed to be followed by diagnostic colonoscopy.
2. In May, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Committee unanimously supported FDA approval of the diagnostic device. The panel agreed that the test is effective, safe and benefits outweigh the risks.
3. A large clinical trial comparing Cologuard with fecal immunochemical testing found Cologuard to have superior detection rates. Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas, while FIT detected 72 percent of cancers and 24 percent of advanced adenomas.
4. CMS has also a issued proposed national coverage determination for Cologuard. The diagnostic test is the first product to be pass through the joint FDA-CMS pilot program review process. Proposed CMS coverage would be once every three years for asymptomatic Medicare beneficiaries age 50 to 85 years old.
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