Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Russell Garlick

Recent Posts

Highlights from the Precision Medicine World Congress

Status of FDA regulation of laboratory developed tests, the promise of precision medicine, and a workshop about achieving accurate NGS laboratory test results

Posted by Russell Garlick on Feb 15, 2017 1:30:00 PM

On January 23-25, 2017 the Precision Medicine World Congress was held in Mountain View, California. The PWMC conference kicked off with Dr. Keith Yamamoto, Vice Chancellor for Science and Policy and Strategy UCSF, with Dr. Robert Califf, FDA Commissioner in a “fireside chat” format. Dr. Califf has been with the FDA for 2 years, has served as Commissioner for 11 months, but has resigned as of January 20th 2017. One of his important parting thoughts presented was how the FDA has been re-energized by the 21st Century Cures Act to hire new scientific talent to implement the President’s Precision Medicine and Cancer Moonshot plans.

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Topics: NGS assays, EGFR, re-validation, limit of detection, ngs validation, FDA Regualtions, Precision Medicine World Congress, mutations, cancer patients, clinical genomics

What lessons for liquid biopsy have been learned from fetal aneuploidy testing?

Posted by Russell Garlick on Sep 30, 2016 1:06:00 PM

Non-invasive prenatal screening (NIPS) is currently offered in over 80 countries, covering over 80 million annual births, with an estimated volume of over one million screening tests performed annually. First offered in 2011, there has been rapid adoption of these genomic tests in the marketplace.

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Topics: NIPS, ctDNA, biomimetic technology, liquid biopsy, circulating DNA, cell-free, testing

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first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff.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

LDT Oversight Counterpoint: Tempering FDA Arguments

Counterpoint to the FDA arguments for laboratory-developed test oversight

Posted by Russell Garlick on Jan 7, 2016 2:56:00 PM

As pointed out by my colleague Trevor Brown in his blog post “LDT Oversight: Why the FDA makes a point” (their case for increased oversight of the new wave of Laboratory Developed Tests [LDTs]), the LDT horse “left the barn”  years ago so why is the FDA calling for a ‘round up’ today? 

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Genetic Profiling of Pediatric Oncology Patients

Recent publication highlights potential of personalized medicine for young cancer patients

Posted by Russell Garlick on Oct 21, 2015 10:38:00 AM

 

There are many challenges for pediatric patients struggling with recurrent or refractory cancer but a recent report and accompanying editorial published in the Journal of American Medical Association brings new hope for patients and their families.1 2This three year study also demonstrates how the principles of precision medicine can be successfully applied with existing DNA and RNA sequencing technologies for many patients.

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Topics: Cancer, Cancer Test, Whole Exome, NGS, RNA-seq, Oncology, Pediatric, Patient Outcome

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