FDA Delays Finalization of Lab-Developed Test (LDT) Draft Guidance–An Opportunity to get forensic LDTs back on the table.

Screen Shot 2016-07-10 at 2.32.07 AMAlthough the current use of these tests is limited to the criminal justice system and professional monitoring programs this may soon change as the American Society of Addiction Medicine is proposing a “new paradigm” of zero-tolerance random widespread drug and alcohol testing. This is outlined in the ASAM White Paper on Drug Testing and described by Robert Dupont in his keynote speech before the Drug and Alcohol Testing Industry Association (DATIA) annual conference in 2012.

The ASAM White paper states drug testing is “vastly underutilized” throughout healthcare and describes the use of drug testing “within the practice of medicine and, beyond that, broadly within American Society.”

As the consequences of a single unregulated “forensic” test result can be grave, far-reaching and even permanent it is critical that these tests be included in the debate on regulation of LDTs.

Evidence based medicine is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.11

Expert opinion is the lowest level of evidence available in the EBM paradigm.12,13 Fortunately, the scientific method and Cochrane type critical analysis of the available evidence is a tool to help people progress toward the truth despite their susceptibilities to unconscious confirmatory bias or conscious confirmatory distortion .14 Unfortunately, no one has used these tools address they panoply of tests of unknown validity that have already entered the market ; poised to be used on virtually everyone.

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