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The article discusses the regulatory framework that might be adopted by the U.S. Food and Drug Administration (FDA) for laboratory developed tests (LDT) based on a discussion paper the agency released on January 13, 2017. The paper covers various industry proposals including the use of a risk-based approach to oversight, the need for an adverse event reporting and the availability of test performance information. The FDA recommended an exemption for LDT already on the market.

The article reports on a white paper from the Association for Molecular Pathology that addresses the consequences of regulatory and reimbursement forces directed against molecular diagnostic testing. Topics include the threat posed by government regulations to the breakthroughs made by mapping of the human genome, and the U.S. Food and Drug Administration's policies that will reformulate existing medical device regulations.