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FDA approves 90% accurate at-home colorectal cancer screening

By Jennifer Bresnick

- The Food and Drug Administration (FDA) has approved an at-home colorectal cancer screening tool that is up to 90% accurate in detecting the common cancer, potentially expanding access to the test to patients who are leery of an invasive colonoscopy.  With one-third of patients failing to receive the recommended screenings, 143,000 new cancer diagnoses, and 50,000 deaths each year, the DNA-based home test could help primary care providers catch the disease early enough to provide adequate treatment.

“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test.”

In a clinical trial, researchers found that the Cologuard test, produced by Exact Sciences, detected 92% of colorectal cancers and 42% of advanced adenomas in a study population of more than 10,000 patients.  The test also provided a correct negative screening for 87% of patients.  The test was less accurate than the common fecal immunochemical test (FIT) in identifying negatives for advanced adenomas.

The results of the trial were so encouraging that CMS proposed Medicare coverage for the test on the same day as the FDA’s announcement.  The test is the first product to be reviewed through a joint FDA-CMS pilot known as “parallel review,” where both agencies examine a product concurrently in order to speed the regulatory process.

“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” said Nancy Stade, CDRH’s deputy director for policy. “The pilot program is ongoing, but we will apply what we have learned to improve the efficiency of the medical device approval pathway for devices that address an important public health need.”

“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” added Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS. “This parallel review represents unprecedented collaboration between the two agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”

CMS will recommend that the test be conducted every three years for Medicare beneficiaries between the ages of 50 and 85 who are otherwise asymptomatic and present an average risk of developing colorectal cancer.  Patients with positive results from Cologuard will be encouraged to undergo a diagnostic colonoscopy in order to confirm the findings.


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