FDA Update on Laboratory Developed Tests Oversight Laura M. St. Martin, M.D., M.P.H. Acting Branch Chief, Human Tissues and Reproduction Branch, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration ACOT Meeting, February 28, 2012

Background ACOT meeting (August 23-24, 2011) agenda item regarding:  FDA guidance document on analyte specific reagents (Sept 2007), and draft guidance on research use only/investigational use only in vitro diagnostics (June 2011)  Concerns over FDA proposed plan to provide greater oversight for laboratory developed tests (LDTs)  Specific concerns re: potential effect on the fields of histocompatibility and immunogenetics

FDA Involvement in Public Discussion FDA convened public meeting in July 2010 to gather input on our intention to propose a regulatory framework to address LDTs FDA received over 100 comments to public docket for IUO/RUO draft guidance from stakeholders expressing support and concern FDA has repeatedly stated in public that any framework will be phased in according to risk, and there will be ample opportunity for stakeholders to provide input

Stakeholder Input Encouraged FDA will consider concerns raised as we develop policies applicable to analyte specific reagents and laboratory devices indicated for research use only, including concerns related to the needs of small patient populations FDA encourages commentary from stakeholders to inform its development of policy related to these reagents, tests, and devices

FDA Commitment FDA recognizes  value of high quality histocompatibility and immunogenetic tests in achieving OPTN goals  value and need for availability of tests for high- resolution HLA typing in unrelated donor hematopoietic stem cell transplantation FDA will provide additional opportunity for input and discussion before taking new steps toward regulation of LDTs used in organ and stem cell transplantation