The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my prior post of August 4th, 2014. In brief, the LDT Guidance proposes a risk-based, phased-in framework for oversight of LDTs that is in accordance with FDAs current regulation of in vitro diagnostic devices (IVDs). The LDT Guidance creates uncertainty for diagnostic innovators and providers of LDTs. What tests will be subject to enhanced oversight? How will innovators adapt to increased regulation? What additional reporting requirements will be required by FDA?

On September 9th, 2014, at the Business of Personalized Medicine Conference in South San Francisco, I led a panel of experts that discussed the LDT Guidance and its possible impact on the diagnostic industry. The panel “Business Models for Diagnostic Innovators – Laboratory Developed Test or In Vitro Diagnostic?” addressed these issues and discussed how diagnostic providers of services or kit manufacturers can pivot to accommodate a changing regulatory environment. In a follow up conversation with Bio Report, Foley & Lardner, LLP partner and September 9th panelist Nate Beaver discussed the LDT Guidance and its possible impact on diagnostic innovators and personalized medicine.

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