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, clinical genomics

AACR 2019 Day One Highlights: Next-Generation Car T Cells

Posted by Catherine Huang on Apr 2, 2019 12:10:00 PM

I’m excited to be at the Annual AACR meeting at the Georgia World Congress Center in Atlanta, GA. AACR is my favorite scientific meeting because each year I am inspired by the remarkable research presented and leave the conference feeling I’ve learned an incredible amount in just a few days.

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Topics: NGS, AACR

Video: See How an EQA Improves Clinical Genomics Testing with Affordable Custom Reference Standards

Posted by Ram Santhanam on Mar 6, 2019 10:52:00 AM

Next-generation sequencing (NGS) has revolutionized how assay developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. As NGS panels grow to include an increasing number of important biomarkers, so too must the reference standards used for development, validation, and routine QC.

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Topics: NGS

Ground Control to Major Tom: Use Controls and Keep Your Assay Running On

Posted by Lorn Davis on Feb 28, 2019 9:55:47 AM

Labs that demonstrate best practice clinical next-generation sequencing (NGS) quality management programs utilize positive run controls, designed for this purpose, to monitor assay analytical performance across each step of the clinical NGS workflow. Common parameters for assessing the analytical performance of a clinical NGS run include sensitivity (true positives), specificity (true negatives),

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Topics: NGS, qc management, iQ NGS

The Full Authority Companion Diagnostic

Posted by Yves Konigshofer on Feb 21, 2019 12:30:00 PM

It is very likely that on your last flight the turbofan engines were controlled by full authority digital engine controls – FADECs for short. FADECs have played a significant role in keeping airline ticket prices low (except during holidays) by continually adjusting engine parameters so that the engine operates with maximum fuel efficiency and within operational limits, allowing pilots to focus on other tasks.

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Topics: NGS, FDA, clinical genomics

Keys to Better Liquid Biopsy Assay Sensitivity – AMP Corporate Workshop Video

Posted by Sam Blier on Jan 24, 2019 10:30:00 AM

“So as everyone here is aware, I’m sure, detection of circulating tumor DNA is challenging. There’s very little of it, to start with.” Hardly a revolutionary statement by Tony Godfrey, PhD, (Associate Chair, Surgical Research and Associate Professor of Surgery, Boston University School of Medicine) but an important acknowledgement from a leading expert of the difficulty faced by laboratorians

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Topics: NGS, ctDNA, AMP, liquid biopsy

Workshop Video: Two Experts Take on Clinical Genomics QC and Standardization at AMP

Posted by Sam Blier on Dec 18, 2018 4:45:00 PM

If you’ve attended the AMP Annual Meeting over the years or seen any of the headlines it generates, you know how next-generation sequencing-based assays are becoming indispensable diagnostic, prognostic, and predictive tools for a growing number of disease states. But just as important as the newest biomarker or latest chemistry – but seemingly less headline-worthy – are NGS quality control and standardization.

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Topics: NGS, AMP, clinical genomics, iQ NGS

Building and Implementing Liquid Biopsy Assays with the Industry’s Most Patient-Like Reference Materials

Posted by Omo Clement, Ph.D. on Oct 24, 2018 9:00:00 AM

SeraCare’s clinical genomics technologies are developed to address challenges faced across the spectrum of NGS assays. From early development of assays – either IVD assay manufacturers or clinical labs building their own LDTs - there is a scarcity of characterized, complex, difficult variants to ensure the assay can robustly detect all the critical genomic variants in a patient sample. Using our highly characterized, reproducible, and GMP-grade NGS standards, laboratories have a wide range of analytical and clinical validation tools to deeply characterize assay performance such as LOD, linearity, specificity, sensitivity, and reproducibility.   

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Topics: NGS, SeraSeq, liquid biopsy, reference materials

Keep Calm and Standardize On

A Panel of Experts Discusses Best Practices for Clinical NGS Quality Management in the Rapidly Evolving Field of Clinical Genomics

Posted by Peter Duncan on Oct 5, 2018 10:00:00 AM

There is that old adage that says the only thing that is constant is change. This is one of those universal truths we have all come to accept. Heck, even Dunkin' Donuts, widely credited as being the inventor of the word “Donut,” is dropping the word from their brand name. Blasphemy! But that is for another blog...

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Topics: NGS, QC Challenges, QC Management Software, qc management

If I Call Out of Tune, Would Mutations Stand Up and Walk Out on Me?

Posted by Matthew Butler on Aug 9, 2018 10:15:00 AM

One of several important steps in next-generation sequencing (NGS) is tuning the many options provided by mutation callers. Providing values for options configures the signal to noise ratio of the impending mutation calls. In theory, providing values that increase the stringency of mutation calls will reduce the number of false positive calls and thus enrich for true positives. In practice, increasing stringency can eliminate true positives.

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Topics: NGS, SeraSeq