We are living at a time when genomic technologies (in particular next-generation sequencing) are revolutionizing the practice of medicine, in particular in the field of oncology. In addition, the US Food and Drug Administration has made it clear that these advanced technologies as they are applied to diagnostic testing need to come under regulatory oversight.
A few months ago, in a post titled “LDT Oversight: Why the FDA Makes a Point” we brought up the points made by the FDA in a publication of 20 case studies where laboratory-developed tests (LDTs) need regulation, where both harm to patients and large economic losses resulted from poorly-executed diagnostic tests. We also bring up in that post the wide range of complexity these tests entail, the distinction between ‘Research Use Only’ compared to GMP and other industry standards for quality control and reliability, and where CLIA fits into this framework.
In a companion post titled “LDT Oversight Counterpoint: Tempering FDA Arguments” we bring up additional considerations, principally how many innovative LDTs such as EGFR genetic profiling have impacted the modern practice of medicine. In addition, the industry group Association for Molecular Pathology (AMP) counterpoint to the 20 laboratory-developed tests that the FDA used in their case study is listed in a table, with AMP’s counterpoint summarized with their argument that CLIA needs to be modernized, rather than the FDA regulating the large number of existing LDT’s available today. (And on that note, it is not even known how many LDTs are available today. This article estimates some 60,000 genetic testing products on the market.)
With our partner, TOMA Biosciences, we will be presenting a webinar entitled “Oncology Sequencing Standards and Regulatory Framework for NGS” on Friday, February 26 2016 at 12 Noon Eastern Time, 9AM Pacific Time (5PM GMT, 6PM CET). You can sign up here.
The presenters will be Dr. Federico Goodsaid, VP of Assay Development and Regulatory Affairs at TOMA Biosciences, who works on the development of and regulatory submissions for NGS reagents for DNA in liquid biopsy samples in oncology. Previously, he was Associate Director for Operations in Genomics and Biomarker Qualification and Coordinator at the Office of Clinical Pharmacology/Office of Translational Sciences/ Center for Drug Evaluation and Research at the United States FDA.
The second presenter will be Trevor Brown, VP of Precision Medicine at SeraCare. He previously held leadership positions in global diagnostics strategy at Luminex Molecular Diagnostics, where he established and led their marketing organization. Mr. Brown has rich commercial experience spanning portfolio planning, M&A due diligence, and development and execution of channel strategies to access the growing precision medicine and laboratory-developed testing markets. He also previously held several commercial leadership roles at BD Biosciences.
Register today, or forward to a friend who may be interested. We hope to see you there!