Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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its first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff.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

Posters from AMP 2015 Available for Download

The 2015 Association for Molecular Pathology (Austin TX) posters about Reference material stabilization technology, recombinant virus, fetal trisomy patient-like material, and somatic tumor mutation profiling.

Posted by Dale Yuzuki on Nov 9, 2015 10:48:00 AM

The Association for Molecular Pathology (AMP) was founded 'to provide structure and leadership to the emerging field of molecular diagnostics', and publishes the Journal of Molecular Diagnostics.

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Topics: Cancer, LDT, Molecular Diagnostics, Accuplex, NIPS, Nipt, Prenatal Test, Posters, Standard, Oncology, SeraSeq, Amp, Conference, Molecular Pathology, Recombinant Virus

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