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.

Read More

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first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff.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

Read More

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

LDT Oversight: Why the FDA makes a point

Laboratory-developed tests are in the spotlight by the US Food and Drug Administration

Posted by Trevor on Dec 21, 2015 1:23:00 PM

Recently, the FDA upped the ante in the ongoing debate over its desire to regulate laboratory developed tests (LDTs) with the release of a report detailing the ‘real and potential harms to patients and to public health’ arising from LDTs.  This debate has been heating up for several years now—not coincidentally with the emergence of precision medicine and the rapid adoption of data-intensive tools such as Next Generation Sequencing (NGS) and the growing pipelines of targeted therapeutics.  One might argue that the horse has already left the barn and the FDA are trying to corral it back in.

Read More

Topics: LDT, 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.

Read More

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

Precision Medicine Perspective

Interview with Condie Carmack, Ph.D. Vice President Translational Medicine, GenomOncology

Posted by Dale Yuzuki on Oct 15, 2015 10:37:00 AM

Dr. Condie Carmack has over 30 years of experience in the life sciences and diagnostic industries, having been prior to GenomOncology the Director of Oncology Programs at Vela Diagnostics, developing an NGS-based system for worldwide regulatory approval, and prior to that helped found (as General Manager) the Cancer Genetics Laboratory at Baylor College of Medicine with Dr. Marilyn Li.
Read More

Topics: LDT, Test Development, Oncology, Interview

Evaluation-Small

Subscribe for Updates

Categories

see all