AMDL Cancer Test Is Denied Quick FDA OK

Medical test maker AMDL planned to meet with the FDA after the agency said the company's DR-70 colorectal cancer test is not equivalent to other tests already on the market.

The company said its consultant, Diagnostic Oncology Clinical Research Organization, received the "non-substantial equivalence" letter. The company hopes to use the test as an adjunct to improve the sensitivity of a currently used colorectal cancer test called the carcinoembryonic antigen, or CEA, test. The company said that the DR-70 test improves the sensitivity of the CEA test by 24 percent compared with using the CEA test alone.

The letter, should it stand, would prevent the company from filing a 510(k) marketing clearance. The clearance route is quicker than having to file a premarket approval application, where the company must submit clinical trial data. AMDL and its consultant will meet with FDA officials to address specific concerns the agency has over the test, the company said.