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.

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Topics: Diagnostics, LDT, Cancer Test, Circulating Tumor DNA, Clinical Testing, NGS, Precision Medicine, Mutation, ctDNA, FDA, Test Development, Reference Material, Oncology

Circulating Tumor DNA Poster at Keystone Symposium

Poster Titled “New Technical Approach to Construct ctDNA Materials for use in Characterizing, Developing and Validating Plasma Assays”, available for download

Posted by Dale Yuzuki on Feb 11, 2016 10:57:00 AM

The Keystone Symposia is an organization with 44 years of history on specialized topics across the fields of molecular and cellular biology. This week in Banff, Alberta, Canada is a Keystone Symposia conference called The Cancer Genome, along with a joint meeting on Genomics and Personalized Medicine. Their Twitter description (@KeystoneSymp) describes the Keystone organization as “A catalyst for accelerating life science discovery and connecting scientists within and across disciplines at symposia worldwide”.

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Topics: Cancer Test, Circulating Tumor DNA, Precision Medicine, Variation, Mutation, ctDNA, Test Development, Reference Material, Oncology, SeraSeq

Video Interview: Developing Aneuploidy Reference Materials

Interview with Dr. Seth Harkins, Principal R&D Scientist

Posted by Dale Yuzuki on Nov 24, 2015 10:50:00 AM

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Topics: Clinical Testing, Precision Medicine, NIPS, Nipt, Maternal Health, Test Development, Reference Material, SeraSeq, Non-Invasive Prenatal Testing

Circulating tumor DNA liquid biopsy needs reference standards

How can you measure something without a ruler?

Posted by Dale Yuzuki on Nov 3, 2015 10:43:00 AM

 

The science of metrology is tightly coupled with biological science, in tandem with biology becoming less descriptive and more quantitative over the past half-century. The US National Institute of Standards and Technology (NIST), an agency of the US Department of Commerce, has been established to ‘promote U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life’.

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Topics: Diagnostics, #AMP2015, Circulating Tumor DNA, ctDNA, Test Development, Reference Material, Standard, Amp

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.
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Topics: LDT, Test Development, Oncology, Interview

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