The series will begin with a roundtable of expert panelists who will provide an overview of the current regulatory landscape for laboratory-developed tests, particularly in light of the FDA's recent decision to delay finalizing its proposed guidance on the issue. Our panelists will discuss how clinical genomics labs can and should ensure the analytical and clinical validity of their tests amid an uncertain regulatory climate. Webinar attendees will be able to ask questions of the panelists during a live question and answer session.
Roundtable Panelists Include:
- Roger Klein, Medical Director, Molecular Oncology, Cleveland Clinic
- Elaine Lyon, Medical Director, Molecular Genetics and Genomics, ARUP Laboratories
- Girish Putcha, Director of Laboratory Science, Palmetto GBA
Next in the webinar series will be three case studies that will focus on the development and validation of specific clinical genomic tests.
Case Study 1: Development and Validation of a Cancer Hotspot Assay
April 13, 2017 at 1pm Eastern
Case Study 2: Establishing Laboratory QC Systems to comply with CAP CLIA and State Regulatory Guidelines
April 27, 2017 at 1pm Eastern
Case Study 3: Development and Validation of Clinical ctDNA Cancer Assays
May 9, 2017 at 1pm Eastern
"Innovations in NGS-based technology are happening faster than industry regulations can keep up with, explained Trevor Brown, Vice President of Precision Medicine at SeraCare, "and this creates challenges for labs that want to be confident in their adoption of these tests and methodologies. Clinical lab directors and scientists want to know what they can and should be doing today to ensure the accuracy and validity of their tests. SeraCare is excited to be part of this conversation, and bring together key opinion leaders to provide practical advice and examples of success."
Please register to attend the four-part webinar series entitled "Catalyzing Implementation of NGS-Based Tests," beginning on Thursday, March 30, 2017 at 11:00am EST, with replays available shortly after completion. Register at:
Additional information on SeraCare's precision medicine products is available at: https://www.seracare.com/about-us/customers/precision-medicine/.
About SeraCare Life Sciences, Inc.
SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only provide assurance of the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).
SeraCare Life Sciences, Inc.
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SOURCE SeraCare Life Sciences, Inc.