FDA's Proposed Oversight of Laboratory Developed Tests – Industry Impact
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鈥檚 鈥淟DT Guidance鈥 was reviewed in detail in my prior post of . 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 鈥Business Models for Diagnostic Innovators 鈥 Laboratory Developed Test or In Vitro Diagnostic?鈥 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, 麻豆直播 & Lardner, LLP partner and September 9th panelist Nate Beaver discussed the LDT Guidance and its possible impact on diagnostic innovators and personalized medicine. Nate shares his insights on this Bio Report .