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SC10 Regulatory and Reimbursement Issues with Multiplex Molecular Assays/Next-Generation Sequencing

DINNER SHORT COURSE 5:30 - 8:30 pm

NGS in Clinical Space: Regulatory Considerations

Melina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, Inc.

  • Next generation sequencing applications and implications
  • Current regulatory pathways
  • Overview of things to consider in developing NGS applications for clinical use
  • NGS in companion diagnostics – roles of pharma and diagnostic partners

Overview of the Molpath CPT Codes

Victoria Pratt, Ph.D., FACMG, Director, Pharmacogenetics Laboratory, Indiana University School of Medicine

  • Difference between Tier 1 and Tier 2
  • How NGS fits in new MolPath CPT codes
  • Overview of how to obtain a CPT code


Melinda CimlerB. Melina Cimler, Ph.D. is Vice President of Quality & Regulatory Affairs at Illumina Inc., leading Illumina's quality, regulatory and government affairs organizations. She has over 24 years of experience in the FDA-regulated diagnostic industry leading regulatory, quality systems, clinical affairs, research, and product development organizations. She has been very actively engaged in global regulatory, government affairs, due diligence and alliance collaborations.

Prior to joining Illumina, Dr. Cimler served as president of PandiaDx Consulting, where she provided regulatory and compliance guidance for the development of in vitro diagnostic products and medical devices. Previously, she held leadership positions in quality, regulatory and government affairs at Beckman Coulter Inc. She also served in senior quality and regulatory roles at Abbott Molecular, Gen-Probe Inc., and C.R. Bard. Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.

Victoria PrattVictoria M. Pratt, PhD, FACMG is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. She is currently Director of the Pharmacogenetics Laboratory at Indiana University School of Medicine. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute. Dr. Pratt served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children. She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the Centers for Disease Control and Prevention (CDC). Dr. Pratt continues to serve on the CDC’s GeT-RM program for reference materials for Molecular Genetics. She is currently serving on the Institute of Medicine’s Roundtable on Translating Genomic-Based Research for Health and the American Medical Association’s (AMA’s) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994. Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI.

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