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By Catholic Online (NEWS CONSORTIUM)

8/12/2014 (2 years ago)

Catholic Online (www.catholic.org)

Cologuard test outweighed its risks, FDA says

Screening for colon cancer is frequently arduous and invasive. Patients need to fast prior to a colonoscopy, and the colonoscopy itself be highly uncomfortable and not always accurate. There's now good news for those at risk. The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

Highlights

By Catholic Online (NEWS CONSORTIUM)

Catholic Online (www.catholic.org)

8/12/2014 (2 years ago)

Published in Health

Keywords: Colon cancer, in-home test, blood in feces, Cologuard


LOS ANGELES, CA (Catholic online) - "This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health says.

The board's decision was based on an FDA panel's unanimous decision last March. At that time, it was determined that the benefits of Exact Sciences Corp.'s Cologuard test outweighed its risks.

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"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 [blood] test," Gutierrez said.

The U.S. Centers for Medicare & Medicaid Services simultaneously announced that it would review the potential for nationwide coverage of the Cologuard test. The agency has gone as far to propose that the stool test be covered for people aged 50 to 85 who have no symptoms of colorectal disease and who are at average risk for colon cancer.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in the news release.

Nearly 143,000 new cases of colorectal cancer were diagnosed in the United States last year. Almost 50,000 Americans died of the disease, according to the U.S. National Cancer Institute.

A study published in March in the New England Journal of Medicine found Cologuard had a very high accuracy rate in spotting colon cancer.

Experts agree that an accurate, noninvasive test would be a huge addition to the fight against colon cancer. One-third of Americans fail to heed public health recommendations to undergo invasive colonoscopy every 10 years starting at age 50.

Commonly used stool tests such as FIT (fecal immunochemical testing) rely on detecting blood in the stool. The new Cologuard test checks for blood as well as abnormal DNA, "with the advantage that some lesions, even cancers, don't bleed very much," Dr. Steven Itzkowitz, director of the gastroenterology fellowship program at the Icahn School of Medicine at Mount Sinai says.

The Cologuard test also features a DNA analysis not included in other fecal exams.

"By increasing the pick-up rate in this way, we found that the new test had a 92 percent sensitivity for detection of colorectal cancer. That kind of result is really unprecedented for a noninvasive stool-based screening."

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