The Shifting Regulatory Sands for Clinical Laboratories
The Department of Health and Human Services recently proposed changes to human subject research protections. The FDA released draft guidance documents that would limit the sale (and distribution) by manufacturers of Research Use Only (RUO) reagents to clinical laboratories and implement FDA oversight for the development of companion diagnostic devices. The FDA has also indicated that three draft guidance documents on laboratory-developed tests (LDTs) will be released in 2012.
Congress entered into the debate on oversight of LDTs with the introduction, on October 14, 2011, of the Modernizing Laboratory Test Standards for Patients Act (H.R. 3207) by Michael Burgess, physician and congressman (R-TX).
On the payer side, Medicare contractor Palmetto GBA has released draft policies on coverage of molecular diagnostic LDTs.
This presentation reviews the major points of these documents and describes how recent changes may affect clinical laboratory testing. The current status and potential impact of the proposed rule from DHHS on patient access to personal laboratory test results is addressed also.
Originally presented December 15, 2011 in Salt Lake City, Utah.
Elaine Lyon, PhD
Medical Director, Genetics Division, ARUP Laboratories
Co-Medical Director, Pharmacogenomics, ARUP Laboratories
Co-Director, Clinical Molecular Genetics Fellowship Program, ARUP Laboratories
Associate Professor of Pathology, University of Utah School of Medicine
Dr. Lyon received her PhD in medical genetics from the University of Alabama at Birmingham and continued with fellowship training in clinical molecular genetics at the University of Utah. Dr. Lyon combines clinical laboratory responsibilities with research and development in human genetics, employing methods for mutation detection by targeted mutation analysis, gene sequencing, gene scanning, exonic-level deletion, and duplications and molecular haplotyping. Dr. Lyon has focused her interest in studies to determine the significance of rare variants and is involved with evaluating and establishing locus-specific databases that combine genetic variants with clinical symptoms.
Ronald L. Weiss, MD, MBA
Staff Hematopathologist, ARUP Laboratories
Professor of Pathology, University of Utah School of Medicine
Dr. Weiss served as ARUP’s chief medical officer and director of laboratories from 1993 until 2002, director of business development from 2002 until 2003, president and chief operating officer from 2003 until 2009, and executive vice president from 2009 until 2010. Dr. Weiss is a professor of pathology at the University of Utah and is board certified in anatomic/clinical pathology, microbiology, and hematology by the American Board of Pathology. Dr. Weiss is past chairman of the board of the American Clinical Laboratory Association and past president of the American Pathology Foundation. He is a fellow of the College of American Pathologists and the American Society for Clinical Pathology. Dr. Weiss received his MD from Creighton University and an MBA from the University of Utah, where he completed his residency training.
After this presentation, participants will be able to:
- Identify proposed changes to the human subjects research protections that may affect clinical laboratories.
- Discuss the implications to clinical laboratories of the FDA’s approach to RUO reagents and companion diagnostics.
- Review the current regulatory framework for LTDs and describe how this may change in the future.
- Review the proposed rule that would allow patients access to their test results directly from laboratories.
University of Utah School of Medicine and ARUP Laboratories