Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Sam Blier

Recent Posts

Expert opinions on LDT transparency and standardization

Posted by Sam Blier on Oct 6, 2017 11:43:00 AM

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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Topics: LDT, clinical genomics, laboratory developed tests, guidelines and regulations, standardized approaches

You can’t validate everything… can you?

Posted by Sam Blier on Sep 21, 2017 10:00:00 AM

“Is there a limit on the type of mutations we would need to validate given that the cost per validation is high?”

This question was recently posted to a panel of clinical genomics experts that we convened for a webinar hosted by GenomeWeb (you can download a full report on the entire series here). Panelists Girish Putcha, MD, PhD, Director of Laboratory Science, Palmetto GBA; Roger Klein, MD, Principal, JD Consulting; and Elaine Lyon, PhD, Medical Director, Molecular Genetics and Genomics, ARUP Laboratories, weighed in with thoughtful responses to a query that’s on the minds of many clinical laboratorians.

 

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Topics: variants, Clinical Genetic Testing, performance-based metrics, synthethic controls, methods-based validation

Accelerating Liquid Biopsy Assay Development

Session Summary from Next Generation Dx Summit 2017

Posted by Sam Blier on Sep 8, 2017 11:15:00 AM

At the 2017 Next Generation Dx Summit in Washington, DC, our CSO, Russell Garlick, PhD, presented a workshop on accelerating liquid biopsy assay development. He has worked closely with a variety of groups in the liquid biopsy space that are developing and validating circulating tumor DNA (ctDNA) assays. He highlighted some common challenges facing the field, and explained how SeraCare has been using these collaborations to develop QC tools specifically for ensuring the robustness of these cutting-edge tests.

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Topics: ctDNA, liquid biopsy, assay development, circulating tumor DNA reference Materials, circulating cell-free DNA, biosynthetic reference materials, assay performance, 2017 Next Generation Dx Summit

 
 

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