Inverness Medical Innovations Inc and its subsidiary Wampole Laboratories LLC, manufacturer and marketer of rapid diagnostic products for the consumer and professional markets, has announced the availability of a new immunoassay fecal occult blood test. The Clearview ULTRA FOB test, which relies on Inverness’ patented lateral flow technology, works by directly detecting human hemoglobin in a fecal specimen. It measures occult blood, a surrogate marker for colon cancer.

Unlike guaiac-based tests, the Clearview ULTRA FOB test does not require the patient to adhere to dietary restrictions. Only one sample is necessary, and the Clearview ULTRA FOB gives results in 5 minutes, using a simple-to-use dipstick test. There are multiple kit and patient configurations to meet the needs of hospitals and physician offices.

The Centers for Medicare & Medicaid Services has recently elected to provide reimbursement for use of fecal occult blood immunoassay tests in colorectal cancer screening at a rate of $18.09 per test compared to the $4.54 that guaiac-based tests are now reimbursed. This decision follows an update to guidelines for the early detection of colorectal cancer proposed by the American Cancer Society last year. The patient-friendly nature of the fecal occult blood immunoassay test is expected to lead to improved compliance and earlier cancer detection.

Wampole Laboratories LLC
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