Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Three liquid biopsy problems solved by the most patient-like ctDNA reference materials

SeraCare’s new Seraseq™ Circulating Tumor Reference Materials

Posted by Dale Yuzuki on Jul 24, 2017 10:00:00 AM

Clinical genomics laboratories are increasingly looking to liquid biopsy cancer assays to complement their current solid tumor assays. Compared to their solid tumor assay counterparts, circulating tumor DNA (ctDNA) assays offer a different set of challenges to consider for clinical labs.  One of the most important of which, is to develop a set of reagents that are appropriately validated to determine the critical performance of the assay across many parameters.  The ctDNA targets of liquid biopsy assays are typically at much lower allelic frequencies and require a robust and reproducibly designed assay to consistently detect these important variants.

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Topics: patient-like, Reference Material, DNA, ctDNA, Circulating Tumor DNA, cell free DNA, cfDNA, DNA Blend

How Many Target Copies Are Present in Your Plasma DNA Sample?

A 0.1% measurement requires a reasonable amount of input material

Posted by Dale Yuzuki on Jun 15, 2017 1:30:00 PM

The field of circulating tumor DNA analysis (ctDNA, also sometimes called in a larger context “liquid biopsy”) holds great promise for monitoring response to cancer treatment, assisting therapeutic choice, monitoring recurrence, and for pre-cancer screening. As such there is a great amount of assay development and ongoing clinical trials; at ClinicalTrials.gov searching for the term "Circulating DNA" you can find over 180 open clinical trials for a wide range of tumor types and interventions.

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Topics: ctDNA, Circulating Tumor DNA, Cancer, plasma DNA Sample, ccfDNA, liquid biopsy, assay development

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

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

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

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

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

 
 

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