Medicare Approves InSure Screening Test for Colorectal Cancer

The Centers for Medicare and Medicaid Services (CMS) has approved use of the InSure Fecal Immunochemical Test as a screening test for colorectal cancer, according to Enterix.

"The decision will allow Medicare beneficiaries to use the InSure brush-sampling test annually after they reach the age of 50," an Enterex statement said.

The InSure test, which received premarketing clearance from the U.S. Food and Drug Administration in January 2001, is available to physicians nationally through Quest Diagnostics.

"This decision is an important step to increase the rate of colorectal cancer screening among Medicare beneficiaries," said Dr. Neil Schlackman, medical director for Enterix. "Colorectal cancer is a preventable disease if it is detected early through regular screening. InSure makes annual screening easier for patients, while providing physicians with accurate, immunoassay-based information."

In a report issued last year, the United States General Accounting Office found that colorectal cancer screening is the least utilized preventive health benefit available to the 40 million Medicare beneficiaries.

Only 25 percent of Medicare beneficiaries are screened each year with traditional guaiac fecal occult blood tests (FOBTs), compared with much higher rates for other regular cancer screening tests such as mammography (75 percent) or Pap smear testing (66 percent).

With InSure, a simple brush is used to collect toilet water from around the stool, rather than actual fecal samples. Unlike guaiac FOBTs, the InSure test does not react with non-human blood (red meat), vitamins (vitamin C), drugs (nonsteroidal anti-inflammatory drugs) or foods (certain vegetables). Therefore, patients do not need to restrict their diets or change medications before or during the two-day sample collection period with the InSure test.

Other sources: Enterex