Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Making the Shift from Technological Innovation to Operational Excellence: Delivering on the Promise Of Next-Generation Sequencing for Personalized Medicine

Posted by Peter Duncan on Apr 22, 2019 9:44:00 AM

As originally seen in The Journal of Precision Medicine March 2019.

Targeted therapies and now recently, immunotherapies, have demonstrated great promise towards increasing response rates, as well as duration of response for cancer patients. This is often achieved by understanding biomarkers associated with therapeutic response and then stratifying patients accordingly.
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Topics: NGS, Precision Medicine, next gen sequencing

Precision Medicine and Clinical Labs: AACR Dinner Seminar Recap

Posted by Trevor Brown on Apr 15, 2019 10:30:00 AM

One of the core aims of precision medicine is to provide a more tailored approach to disease diagnosis, therapy selection, and patient monitoring to improve the overall quality of life for patients with disease. Indeed, this aim has been at the heart of the high interest and study of the potential of liquid biopsies to improve patient care in earlier detection of cancer, treatment, and surveillance.

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Topics: Precision Medicine, cfDNA, aacr

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: Cancer, NGS, Precision Medicine, FDA, NGS assays, EGFR, ngs validation, clinical genomics

Reference Materials for Your Unique Reproducibility Needs

The distinction between accuracy and precision.

Posted by Matt Ryder on Oct 12, 2016 11:06:00 AM

If you took a university introductory statistics course, you may have learned the distinction between accuracy and precision.  It may likely have been presented with an archery analogy, where ‘Accurate’ was represented by arrows loosely clustered around the target’s bull’s-eye, ‘Precise’ was shown as a tight grouping displaced from the center, and ‘Accurate and Precise’ was depicted as what every archer aims for, a tight grouping directly at the bull’s-eye.  Suddenly, words that are used interchangeably in everyday conversation took on dramatically different meanings.


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Topics: NGS, Precision Medicine, FDA, Reference Material, SeraSeq, NGS assays, Sequencing quality control, allele frequencies, NGS reference materials

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, 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, Test Development, Reference Material, SeraSeq, Non-Invasive Prenatal Testing

Association for Molecular Pathology 2015 Conference Highlights

Two presentations of note from the 2015 AMP Conference, Austin Texas #AMP2015

Posted by Dale Yuzuki on Nov 13, 2015 10:46:00 AM

 

Micrograph of Lung Carcinoma Fine Needle Aspirate courtesy of Ed Uthman via Flickr

This year's Association for Molecular Pathology conference was held in Austin Texas November 4-7 2015 had the theme of 'Realizing the Dream of Precision Medicine'. Here are a few of the presentations that stood out as outstanding, and the conference program indicates where the field of molecular pathology currently places its emphasis (which is primarily oncology) and where it may be headed in the coming years (including rare genetic disorders, non-invasive prenatal testing, and even a plenary on the human microbiome).

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Topics: Cancer, Precision Medicine, Oncology, 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, Precision Medicine, Test Development, Oncology

What is Precision Medicine?

Posted by Dale Yuzuki on Oct 13, 2015 10:37:00 AM

In 2011, the National Academy of Science published the results of a year-long committee effort called ‘Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease’. This committee was charged to explore the feasibility and need to develop a new taxonomy of human disease based upon molecular biology, with the concept that with an explosion of molecular data about individuals with disease, there was a great untapped opportunity to use these data to improve health.

FLICKR, JOHN GOODE

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Topics: Diagnostics, Precision Medicine, Reference Material, SeraSeq