Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

FDA-AACR Liquid Biopsies in Oncology Drug and Device Workshop

Important information for assay development and review by the FDA

Posted by Yves Konigshofer on Aug 8, 2016 9:09:00 AM

The presentations during the FDA-AACR Liquid Biopsies in Oncology Drug and Device Development Workshop on July 19, 2016 included several important pieces of information that will likely guide the development of assays and their review by the FDA.

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Topics: Diagnostics, LDT, Cancer Test, Circulating Tumor DNA, Clinical Testing, NGS, Precision Medicine, Mutation, ctDNA, FDA, Test Development, Reference Material, Oncology

IVD Guidance for NGS Manufacturers

Posted by Russell Garlick on Jul 14, 2016 3:30:00 PM

After 17 months of deliberations since its first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff. The document “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” was published online on July 6, 2016. This document (PDF located here) is for analytical validity and not for clinical validation.

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Topics: LDT, Molecular Diagnostics, Clinical Testing, NGS, FDA, Reference Material

Video Interview: Developing Aneuploidy Reference Materials

Interview with Dr. Seth Harkins, Principal R&D Scientist

Posted by Dale Yuzuki on Nov 24, 2015 10:50:00 AM

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Topics: Clinical Testing, Precision Medicine, NIPS, Nipt, Maternal Health, Test Development, Reference Material, SeraSeq, Non-Invasive Prenatal Testing

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