CONFERENCE SERIES: Biomarkers & Diagnostics

Recorded at: Biomarkers & Diagnostics World Congress

Digital Course: Laboratory-Developed Tests

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About this Product:

Laboratory-developed tests, which are developed, validated and performed by clinical laboratories, have come under increased scrutiny by the FDA. Cambridge Healthtech Institute's Laboratory-Developed Tests Digital Course will cover the latest developments from the FDA and the positions and recommendations put forward by medical and industry professional societies; the challenges of meeting CLIA regulations in the new age of genomics; and the complexities of implementing NGS assays into clinical laboratories.



Product Details:
4 Presentations
124 Slides
133 Minutes
Individual: $345
Site License: $1380

Formats Available:
Digital Download
On Demand 


Agenda at a Glance:

Regulatory Issues Facing Laboratory-Developed Tests

Peter M. Kazon, General Counsel, American Clinical Laboratory Association

The development of molecular diagnostics has been accompanied by a host of regulatory issues, including coding, billing and FDA issues. This session will review recent changes affecting these codes as well as the position of Medicare on how to pay for these tests and tests including an algorithm, also referred to as MAAAs. It will review the latest developments from the FDA concerning whether such tests will require FDA pre-market approval or clearance, and what action FDA is likely to take in the future. It will also review other actions that affect these tests, such as the new MolDx program being overseen by Palmetto GBA, a Medicare contractor.

LDTs in the Context of CLIA: An NIH Experience

Daniel Edelman, Ph.D., Facility Head, Clinical Molecular Profiling Core, National Cancer Institute, NIH

The mission of the Clinical Molecular Profiling Core (CMPC) of the National Cancer Institute (NCI) is to provide state of the art genomic testing for specimens obtained from NCI clinical trials. The greatest impact is effected where test results have immediate clinical application for personalized cancer care for individual patients enrolled in these trials. To that end, the CMPC is CLIA certified and provides a growing set of clinical test modalities. In this talk we'll discuss the challenges of meeting CLIA regulations in this new age of genomics at NIH for high-complexity assays that did not exist as diagnostic tests when the federal guidelines were written.

Next-Generation Sequencing Assays as Laboratory-Developed Tests

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director, Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

As next-generation sequencing (NGS) technologies improve in accuracy and cost effectiveness, they will become standard in clinical laboratories. Multi-gene panels, exome or genome analysis are alternative approaches. With the complexity of genomic scale sequencing, implementing NGS assays into clinical laboratories requires expertise in laboratory techniques, informatics and interpretation. CLIA-certified clinical laboratories are developing NGS assays as laboratory-developed tests (LDTs). The presentation will discuss how NGS assays are "procedures" involving input from health care professionals, and how they fit under the category of high complexity LDTs.

LDT Regulation Guidance from the FDA: Where Does It Stand after Three Years?

Stephen P. Day, Ph.D., Director, Medical Affairs, Hologic

The FDA's announced intent to further regulate laboratory developed tests (LDTs) enters its third year without the issuance of the anticipated guidance. This presentation will summarize what the FDA has made publicly available on the subject up to this time, the positions and recommendations put forward by medical and industry professional societies, and how it will potentially affect clinical laboratories offering LDTs and the delivery of quality medical care.

Speaker Biographies:

Peter KazonPeter M. Kazon, General Counsel, American Clinical Laboratory Association

Peter Kazon has over 25 years of experience assisting companies and individuals in negotiating the complex legal and regulatory issues that healthcare providers routinely face. Among his specialties are advising clinical laboratories and diagnostic companies on regulatory and compliance matters, and assisting companies with emerging medical technologies with coverage, coding and reimbursement issues. In addition, Peter assists companies on compliance with the Food, Drug and Cosmetic Act and its recent amendments, with particular attention to FDA actions affecting in vitro diagnostic products. After receiving a B.A., magna cum laude, from Tufts University in 1975, Mr. Kazon earned his J.D. from Temple University in 1978. After law school, Mr. Kazon worked for five years at the Federal Trade Commission's Bureau of Competition, where he specialized in healthcare antitrust matters.

Daniel EdelmanDaniel Edelman, Ph.D., Facility Head, Clinical Molecular Profiling Core, National Cancer Institute, NIH

Dr. Edelman earned his M.S. in Applied Molecular Biology at the University of MD Baltimore County in 1993 and worked as a research associate at the Baltimore VAMC investigating prion diseases. He was a founding member (1994) of the clinical Molecular Diagnostics Laboratory in the University of MD Medical Center, Baltimore, MD and in 1997 transitioned into dissertation research under Dr. Niel Constantine, University of MD Baltimore. There he explored the diagnostics of HHV-8 infection and received his Ph.D. in Medical Pathology in 2005. Thereafter he worked for the FDA/CDRH/OIVD as an in vitro diagnostic device scientific reviewer. Since 2007, Dan has been the core manager of the Clinical Molecular Profiling Core in the Center for Cancer Research/NCI/NIH. The core is compliant for CLIA '88 and is actively involved in clinical cancer trials involving personalized medicine using state of the art genomic methodologies.

Elaine LyonElaine Lyon, Ph.D., Medical Director, Molecular Genetics; Co-Medical Director, Pharmacogenomics, ARUP Laboratories; Associate Professor, University of Utah

Dr. Elaine Lyon is an Associate Professor in the Department of Pathology, University of Utah School of Medicine. In addition to her academic duties, Dr. Lyon is the Medical Director of Molecular Genetics and Genomics and Co-medical Director of Pharmacogenetics at ARUP Laboratories, where she has overseen the growth of these laboratories for over 15 years. As a Medical Director, Dr. Lyon transitions new instrumentation and new molecular assays for inherited conditions into clinical diagnostics applications. In addition, she reviews molecular test results and provides sequence variant interpretation.

Stephen DayStephen P. Day, Ph.D., Director, Medical Affairs, Hologic

Dr. Day is Director of Medical Affairs for Hologic|Gen-Probe, a women's healthcare company. His career has included faculty positions in academic and public health medicine including that of Chief of Molecular Diagnostics for the Wisconsin State Laboratory of Hygiene, Director of Molecular Diagnostics at a national reference laboratory, and Director of Medical Affairs at several in vitro diagnostic device manufacturers of molecular tests. He has served in elected and appointed positions in the Association for Molecular Pathology and has overseen multiple clinical trials for both 510(k) and PMA submissions to the FDA. He is also a reviewer for several scientific journals. He holds several bachelor's degrees in science, an M.S. from North Carolina State University, a Ph.D. from the University of South Alabama, and completed further postdoctoral training in molecular virology at the University of North Carolina at Chapel Hill.

About the Conference:

The signature event in Cambridge Healthtech Institute's Biomarkers and Diagnostics Series, the Ninth Annual Biomarkers & Diagnostics World Congress 2013 is dedicated to all areas of biomarker research spanning the pharmaceutical and diagnostic pipeline. The meeting brings together a unique and international mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers—making the Congress a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies. The Congress also offers a balance of scientific sessions covering the latest research and strategic presentations and brainstorming sessions for the decision makers. Now in its ninth year, the Biomarkers & Diagnostics World Congress is the leading annual meeting dedicated to biomarker and diagnostics research and implementation that consistently delivers a cutting-edge agenda, 400+ senior delegates, and a sold-out exhibit hall.



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