VICC - FDA LDT Discussion
Drs. Eric Konnick, Yassmine Akkari, and Andy Bredemeyer discuss the recent decisions and actions surrounding FDA governance of laboratory-developed tests (LDTs) - the Final Rule, current lawsuits, and what it all means for those of us in cancer genomics.
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Meet the speaker:
Dr. Andrew Bredemeyer
Senior Vice President, MCOE
Dr. Bredemeyer is a product leader at Velsera, creating valuable solutions for clinical genomic laboratories through the development and growth of Velsera's LDT and IVD platforms. In collaboration with Velsera's Knowledgebase and software teams, he has helped design an automated tertiary analysis and clinical interpretation system and partnered with biocurators to create curation processes and automation for medical device compliance. Dr. Bredemeyer holds a Ph.D. in Immunology from Washington University in St. Louis. He served in policy and finance roles at the NIH and at Massachusetts General Hospital research labs. Dr. Bredemeyer helped lead NGS-based clinical assay development and validation efforts at Washington University’s Genomics and Pathology Services laboratory, an early pioneer in clinical NGS testing.
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