Where FDA Is Heading in Regulating Laboratory-Developed Tests

Why Should You Attend:

Laboratories are developing and using custom diagnostic tests to keep pace with the changing face of disease as well as to best serve both patients and clinicians alike. Though LDTs have long been subject to the regulatory requirements under the Clinical Laboratory Improvement Amendments (CLIA) FDA’s growing involvement with LDTs leaves affected labs with trying to understand how they would be affected by the prospect for additional federal oversight. Meantime, a draft for new congressional legislation, the Diagnostics Accuracy and Innovation Act (DAIA) which would affect the regulatory framework of both LDTs and in vitro diagnostic (IVD) test kits adds yet another piece to the complex federal jigsaw puzzle for regulating LDTs. Likewise, FDA has recently announced steps to ease premarket approval for laboratory developed tests (LDTs) while acknowledging that comprehensive legislation ultimately is the best way to address regulation of LDTs.

This webinar details the history of federal regulation of laboratory-developed tests including requirements under CLIA and FDA’s interpretation of its authority under the Food Drug & Cosmetic Act (FDCA). Key policy pronouncements by the FDA for overseeing LDTs will be detailed including: the agency’s stance on a subset of LDTs known as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs); FDA’s plan for a comprehensive framework for LDT oversight; its release of draft documents describing the agency’s proposed regulatory framework for LDTs and subsequent withdrawal, and FDA’s “discussion paper” which outlines a substantially revised “possible approach” to the oversight of LDTs. Possible new federal legislation now being discussed that would affect LDT regulation will also be covered along with the current outlook for further action by the Trump Administration and/or Congress affecting LDT oversight.

Areas Covered in the Webinar:

• Regulatory requirements under CLIA
• FDA’s interpretation of its authority to regulate lab tests under the Food Drug & Cosmetic Act
• FDA’s reasoning for applying enforcement discretion to LDTs
• The agency’s plan and subsequent proposed guidance to regulate a newly defined subset of LDTs, In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
• FDA’s position for issuing warning letters to labs regarding marketing of specific tests
• FDA approach under its proposed regulatory framework for LDTs
• Industry’s reasoning for opposing FDA oversight of LDTs
• Rationale for the agency’s decision to withdraw its proposed regulatory guidance of LDTs
• FDA latest thinking on “possible approach” to regulating LDTs
• How possible new federal legislation would impact LDT oversight
• Outlook for further regulation of LDTs by FDA and/or Congress

Who Will Benefit:

• Clinical pathologists
• Senior laboratory executives in academic, research, hospital and independent labs including CEOs, COOs, CFOs
• Medical directors
• Administrative directors & senior managers
• Directors of reimbursement, billing & finance
• Head of legal and compliance office

Dennis Weissman
President, Dennis Weissman and Associates LLC

Dennis Weissman is a nationally known independent analyst and thought leaders in the clinical laboratory and pathology sectors for over three decades. Dennis is president of Dennis Weissman & Associates, LLC of Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, public policy monitoring & advice and business leadership to diagnostic and life science companies and organizations. He has expertise in Medicare and health care reform policies and trends; clinical lab and pathology payment and compliance policies as well as M&A and business issues and direction to diagnostic and life science companies.

Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) from 1979 through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports; webinars and live conferences. Prior to G2, he served as Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistance Secretary for Health, U.S. Department of Health, Education & Welfare (now HHS).

Topic Background:

While the vast majority of clinical laboratory tests are commercial tests which are manufactured and marketed by medical device companies to multiple laboratories, some tests are developed, validated and made available to patients by a specific lab and have not historically been required to go through the Food and Drug Administration (FDA) approval and clearance process applied to commercially available lab tests. These proprietary laboratory-developed tests (LDTs) are used solely within that particular lab and are not distributed or sold to other labs, hospitals, or physicians to perform on their own. LDTs are developed by academic, hospital and independent clinical labs according to their own procedures and are often created in response to unmet clinical needs and are often used for early diagnosis, monitoring and guiding of patient treatment. In addition, LDTs may also be used to diagnose and assess diseases and disorders for which there is no currently available commercial test kit approved by the FDA, such as rare and emergent diseases, or those with small patient populations. The increasing complexity, availability and growing use of LDTs to diagnose common but serious medical conditions such as cancer and heart disease, has sparked FDA’s renewed scrutiny and related policy positions on LDTs which have drawn the attention of Congress and raised serious concerns inside the lab industry.

Follow us :