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

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first open meeting February 20, 2015 on NGS IVD assay oversight, the U.S. Food and Drug Administration (FDA) issued DRAFT guidance for Stakeholders and FDA staff.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

Mary-Claire King at the European Society for Human Genetics 2016

Her vision of genomic medicine as a dialogue at ESHG 2016 in Barcelona, Spain

Posted by Dale Yuzuki on Jun 6, 2016 3:29:24 PM

Mary-Claire King is Professor of Genome Sciences and of Medicine (Medical Genetics) at the University of Washington (Seattle, WA), who first described a single gene on chromosome 17q21 (which she named BRCA1) being responsible for breast and ovarian cancer in many families. This work, published in Science in 1990, also revolutionized the study of many other common, single-gene diseases that are inherited in nature, and led to the discovery of BRCA2. 

 

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Topics: Cancer, Inherited Disease, Oncology

SeraCare introduces AccuPlex™ Zika Reference Material

Recombinant viral technology to assist development of PCR-based Zika Virus diagnostic assays

Posted by Dale Yuzuki on May 10, 2016 9:00:00 AM

Guest author: Han Joo Lee, Ph.D., SeraCare Technical Product Manager

A cursory look at recent Zika Virus outbreak news headlines is alarming enough: “Zika Virus birth defects may be the ‘Tip of the Iceberg’, experts say”; “Brain damage in Zika babies is far worse than doctors expected”; and “Zika mutates extremely quickly, which is why it’s so scary”. In addition, for the United States the estimated range maps of the Aedes aegypti and Aedes albopictus have been recently updated, widening the range previously reported to all but 10 states within the US.

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Topics: Accuplex, Genomics, viral technology, zika virus

American Association for Cancer Research 2016 ctDNA highlights

Circulating tumor DNA, along with immunotherapy, are two major themes of #AACR16

Posted by Dale Yuzuki on May 2, 2016 9:00:00 AM

At the American Association for Cancer Research conference recently held in New Orleans, LA (April 16 - April 20, 2016) one theme that generated considerable interest was circulating tumor DNA detection, sometimes called liquid biopsy (although that term also encompasses circulating tumor cells). A few of the ctDNA presentations are highlighted below.

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Topics: Cancer, Circulating Tumor DNA, immunotherapy

Previewing the American Association for Cancer Research 2016 Conference #AACR16

The premier cancer research conference heads to the New Orleans Convention Center April 17 - 20, 2016

Posted by Dale Yuzuki on Apr 16, 2016 9:00:00 AM

With over “Cancer Moonshot: A Call to Action” 20,000 scientists, the American Association for Cancer Research conference describes itself as a ‘must-attend event for cancer researchers and the broader cancer community’. One sign of the prominence of this event is the fact that US Vice President Joseph Biden will be delivering a special closing address, in connection with the recent announcement of the  announced at the recent World Economic Forum.

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Topics: Cancer, Genomics, cancer research

The FDA NGS-based Oncology Panels Workshop

Impressions from the first FDA workshop focusing on NGS-based oncology diagnostic tests

Posted by Yves Konigshofer on Apr 1, 2016 11:08:00 AM

The U.S. Food and Drug Administration on February 25, 2016 held an all-day public workshop entitled “Next Generation Sequencing-based Oncology Panels” at their White Oak campus in Silver Spring, Maryland. Companion diagnostics were a recurring theme of the initial FDA presentations at this Next Generation Sequencing-Based Oncology Panels Workshop and these important tests will be our focus here. The slides that were presented at the workshop are available (PDF) and are referenced below, and those presented by SeraCare’s CSO Russell Garlick start on page 196.

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Circulating Tumor DNA Reference Materials

The Seraseq Circulating Tumor DNA-I Reference Materials officially launches, as well as a Circulating Tumor DNA-I Mutation Mix

Posted by Dale Yuzuki on Mar 24, 2016 11:07:00 AM

Circulating tumor DNA detection by real-time quantitative PCR, digital PCR, or next-generation sequencing has garnered an abundance of scientific and commercial interest. We have written before about the critical need for standards and reference materials for this emerging translational oncology research and applied domains and we are pleased to report the launch of the Seraseq Circulating Tumor DNA Reference Materials.

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Highlights from the 2016 Molecular Medicine Tri-Conference

Diagnosing inherited disease, processing FFPE samples, state-of-the-art oncology in North Carolina, and developments in circulating tumor DNA technology

Posted by Dale Yuzuki on Mar 22, 2016 11:05:00 AM

We are living through a time of rapid change in the clinical genetics laboratory, though at times it may appear that change doesn’t occur fast enough given the challenges within the existing healthcare system. At the recent Molecular Medicine Tri-Conference held in San Francisco March 7 through 11 2016, here are a few summary highlights of the conference.

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Topics: Cancer, Circulating Tumor DNA, Inherited Disease, Genetics, Genomics, ctDNA, Reference Material, Oncology, Rare Disease

Molecular Tri-Conference Preview (San Francisco CA March 7-11 2016)

A molecular medicine, drug discovery and diagnostics conference recognizing the potential of new technologies and their role in mitigating disease and identifying transformative treatments

Posted by Dale Yuzuki on Feb 29, 2016 10:16:00 AM

The 23rd annual Molecular Medicine Tri-Conference will be in San Francisco, California March 7 through 11, 2016, and will cover topics ranging from personalized diagnostics, circulating tumor cells, and clinical NGS diagnostics through integrated bioinformatics, frontiers in gene editing, cancer immunotherapy and molecular diagnostics for infectious disease.

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