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FDA CLIA waiver for ABMC's Rapid TOX drugs of abuse tests

This article was originally published in Clinica

Executive Summary

The US FDA has granted a CLIA waiver to American Bio Medica Corporation (ABMC's) Rapid TOX point-of-care (POC) drug test product line. This means the tests can be used by non-laboratory-trained physicians and other healthcare professionals in CLIA-certified labs. The waiver covers all 14 drugs that Kinderhook, New York-based ABMC currently tests for, including amphetamines, barbiturates, marijuana and tricyclic antidepressants. The clearance also covers two different cut-off levels for the firm's opiate and cocaine tests. The tests analyse urine samples and produce results in around five minutes. ABMC hopes to complete negotiations with distributors for the hospital and physician markets, and expects to see an immediate impact on sales.

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