Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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

Introducing A New Reference Material for KRAS Molecular Testing

Seraseq FFPE Tumor KRAS Reference Material Kit

Posted by Matt Ryder on Jan 31, 2017 3:45:00 PM

During my time spent in academia, I studied in a laboratory focused on molecular switches.  Although cellular signaling cascades appear as nothing more than incomprehensible spiderwebs when viewed graphically, the concept is very straightforward: certain molecules can act to regulate cellular processes by functioning like electrical switches.  Just as light switches in your home complete or break a circuit to control the flow of electrical current, molecular switches such as Ras GTPases (PDF) control whether certain signals can elicit a cellular response.

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Topics: Molecular Testing, oncogene, New Reference Material, Tri-Con, Variant Allele Frequencies, EGFR, KRAS

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