Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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Expert opinions on LDT transparency and standardization

Category: LDT, clinical genomics

Posted by Sam Blier on Oct 6, 2017
Laboratory-developed tests (LDTs) have proliferated in the absence of clear guidelines and regulations. So how can laboratorians, physicians, and patients be assured of the quality of the diagnostic result? A panel of clinical genomics experts (Girish Putcha, MD, PhD, Director of Laboratory Science, Palmetto GBA; Roger Klein, MD, Principal, JD Consulting; Elaine Lyon, PhD, Medical Director, Molecular Genetics and Genomics, ARUP Laboratories; and Russell Garlick, PhD, CSO, SeraCare) delved into this topic during the audience Q&A session of a recent webinar hosted by GenomeWeb (you can download a full report on the entire series here).  
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FDA-AACR Liquid Biopsies in Oncology Drug and Device Workshop

Category: cancer, LDT, NGS, ctDNA, FDA, clinical genomics, reference materials

Posted by Yves Konigshofer, PhD on Aug 8, 2016
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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IVD Guidance for NGS Manufacturers

Category: LDT, NGS, FDA, clinical genomics, reference materials

Posted by Russell Garlick, PhD on Jul 14, 2016
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its first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff.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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LDT Oversight: Why the FDA makes a point

Category: LDT, FDA, reference materials

Posted by Trevor Brown on Dec 21, 2015
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.
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Posters from AMP 2015 Available for Download

Category: cancer, LDT, Accuplex, NIPT, SeraSeq, AMP, Molecular Pathology

Posted by Dale Yuzuki on Nov 9, 2015
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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Precision Medicine Perspective

Category: cancer, LDT, clinical genomics

Posted by Dale Yuzuki on Oct 15, 2015
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.
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