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FDA Approves Noninvasive, DNA-Based Colon Cancer Screening Test


Last week, the FDA announced its approval of Cologuard, a noninvasive colon cancer screening test based on DNA technology, for average-risk patients.

Cologuard is the first noninvasive screening test for colon cancer that analyzes both stool DNA and blood in stool. The test was developed through a collaboration between Exact Sciences and researchers from the Mayo Clinic, and underwent extensive examination during a clinical study. The study demonstrated that the test detects 92 percent of cancers and 69 percent of the most advanced precancers in average-risk patients.

The results of this study—one of the most extensive colon cancer screening studies ever conducted in the U.S.—were published in April 2014 in the New England Journal of Medicine’s Multi-target Stool DNA Testing for Colorectal-Cancer Screening”.

“The robustly conducted research as part of this FDA approval process has proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer,” said David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test. “The test is designed for high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives.”

The test is available through health care providers, and offers people 50 and older at average risk for colon cancer an easy–to–use screening test they can do in the privacy of their own home. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre–paid mailer.

Upon FDA approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS). Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage. A final National Coverage Determination is expected to be posted in October/November of this year after a public comment period.

Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. You can find more information on Cologuard at

Other News From Around the Web

  • A new study found that sigmoidoscopy, a less invasive, cheaper alternative to colonoscopy, reduces people's risk of developing or dying from the disease.
  • Research from the UK suggests that a higher body mass index (BMI) increases the risk of 10 common cancers.
  • Colonoscopies may be riskier for colon cancer survivors over the age of 75.

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Topics: Colon Cancer News