Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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: #AMP2018, ctDNA, NGS reference materials

Tips for Better EGFR Mutation Testing

Posted by Catherine Huang on Jan 10, 2019 11:30:00 AM

Tips for Better EGFR Mutation Testing

Molecular testing of genomic alterations in the EGFR gene is critical to personalized treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). However, the testing landscape is complex. Some mutations confer sensitivity, and others confer resistance to anti-EGFR targeted therapies.

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Topics: ctDNA, Ffpe, EGFR, SeraSeq

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: iQ NGS, #AMP2018, clinical genomics

Two Must-See Liquid Biopsy Poster Videos From AMP 2018

Posted by Sam Blier on Dec 7, 2018 2:19:00 PM

 

Of the many fantastic posters presented at AMP’s Annual Meeting in San Antonio, two concerning NGS-based liquid biopsy assays stood out. Both presenters described how their organizations are working to reliably detect pathogenic variants at extremely low allele frequencies – efforts critical to the clinical adoption of NGS-based liquid biopsy assays.

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Topics: #AMP2018, ctDNA, cfDNA, SeraSeq

The Trouble with Troubleshooting Clinical NGS

Posted by Peter Duncan on Nov 15, 2018 11:00:00 AM
Figure 1 Frustrated Actor in PocketHose Infomercial

Have you ever seen those late night infomercials? One of the things I love whenever I have watched these is the over-the-top acting to depict whatever frustration the target audience must be feeling if they can’t coil up their garden hose or manage their closet space.

As frustrated as these actors are, I can’t help but imagine what an actor’s depiction of the level of frustration that a clinical genomics lab director might be feeling when things don’t go according to plan while carrying out an NGS assay.

Figure 1 Frustrated Actor in PocketHose Infomercial

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Topics: iQ NGS, QC Management Software, QC Challenges

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: reference materials, liquid biopsy, patient-like, SeraSeq, Clinical NGS Assays

To Realize the Potential of Liquid Biopsies, Focus on Higher Quality Research and Clinical Data Sets

Posted by Dan Brudzewsky on Oct 15, 2018 9:30:00 AM

Liquid biopsy requires better standardization to realize all the new possibilities for studying metastasis, heterogenicity, treatment efficacy, and disease recurrence. Furthermore, it is critical for clinicians to have confidence in liquid biopsy data to diagnose and treat patients. This is only achievable when consistent and high-quality data is generated at research and all clinical centers. The Liquid Biopsies course at EMBL Advanced Training Centre provides a unique practical training in best practices and pitfalls on the complete liquid biopsy workflow, from sample preparation to data analysis. The course is targeted for clinical laboratory and research scientists interested in learning all aspects of liquid biopsy testing.

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Topics: liquid biopsy, SeraSeq

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 Management Software, QC Management Software, QC Challenges

Are You Ready to Take the “Red Pill” and Enter a World of Standardized Clinical NGS Assays?

Posted by Peter Duncan on Sep 21, 2018 9:30:00 AM

As seen in the original “The Matrix,” Morpheus offers Neo two pills - a blue one and a red one. Take the blue pill and you continue right where you left off. But take the red pill and suddenly your outlook on things will change and new possibilities emerge.

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As Immunotherapy Use Rises, Critical Gaps Remain in Harmonizing Tumor Mutational Burden Measurements

A consortium of industry experts has combined forces to solve TMB challenges.

Posted by Trevor Brown on Sep 19, 2018 5:15:00 PM

Recent clinical studies of immuno-oncology (I-O) checkpoint inhibitors have indicated that the tumor burden in a cancer patient’s genome may be predictive of positive response to I-O therapies such as Keytruda® and Opdivo®. The tumor mutational burden (TMB), that is, the number of mutations per megabase of sequenced tumor sample as determined by whole exome sequencing (WES), is currently the most  promising biomarker for cancer patient selection and stratification in many clinical trials. Numerous clinical studies are underway to elucidate and validate the role of TMB in I-O treatment decision making and therapeutic response.

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