Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Presenting NTRK Reference Materials for Global Assay Standardization at AACR 2019

Posted by Catherine Huang on Apr 8, 2019 3:00:00 PM

On the last morning of AACR 2019, I had the privilege of presenting a poster together with my colleague, Sebastian Bender from Bayer AG, in Berlin. Because of this, I didn’t have a chance to attend any talks, but I still wanted to finish out my blog series with highlights from each day of the conference.

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Topics: SeraSeq, fusion RNA, aacr, NTRK

Customer Data: Use of Seraseq ctDNA Reference Samples to Validate Detection of Low Frequency Variants in a cfDNA-based NGS Lung Cancer Panel

Posted by Omo Clement, Ph.D. on Feb 14, 2019 2:10:00 PM

At the recently-concluded 2018 AMP Meeting, researchers at the New York Presbyterian Hospital (NYPH) and Weill Cornell Medical Center (WCMC) presented a poster1 on the validation of an Oncomine™ cell-free DNA Lung Assay using ctDNA NGS standards developed by SeraCare (Seraseq® ctDNA v2 Reference Materials),2

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Topics: ctDNA, SeraSeq, Amp, cfDNA, Lung Cancer

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, SeraSeq, Ffpe, EGFR

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: ctDNA, SeraSeq, Amp, liquid biopsy, cfDNA

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: SeraSeq, liquid biopsy, NGS reference materials, Clinical NGS Assays, reference materials

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: SeraSeq, liquid biopsy

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: SeraSeq, NGS reference materials, Clinical NGS Assays

How A New Generation of ctDNA Reference Standards Are Enabling the Promise of Precision Medicine

Posted by Omo Clement, Ph.D. on Jun 14, 2018 10:00:00 AM

An important goal in cancer disease management is early detection. When detected early, disease progression can be significantly mitigated with a plethora of options (targeted therapy, chemotherapy, surgery, etc.) available to medical practitioners, to afford progression free survival and a higher quality of life. A great promise of liquid biopsies is the possibility of early detection of cancer long before clear evidence of lesions and tumor growth observable by imaging or other techniques.1 As proxy for solid tissue biopsies, plasma-based liquid biopsy application is rapidly gaining traction in cancer disease diagnosis, progression, monitoring, and in predicting resistance to treatment options.2

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Topics: Cancer, ctDNA, SeraSeq, NGS assays, liquid biopsy, ccfDNA, NGS reference materials, Clinical NGS Assays

FAQ: What to do when your NGS assay fails to detect a variant contained in Seraseq Reference Materials?

Posted by Catherine Huang on Jun 11, 2018 1:15:00 PM

Highly multiplexed reference materials are particularly valuable when developing and optimizing new NGS assays because they allow you to evaluate the performance of your assay across a large number of variants including different variant types (SNVs, indels, homopolymeric variants, etc.) and contexts. However, it can be frustrating when a variant in the reference material is not detected, or not detected at the expected variant allele frequency. Troubleshooting such issues can give new insight into the performance of the assay. Here we share some stories from Seraseq™ users where the lack of detection of one or more variants at the expected levels helped them improve their assay or set more appropriate QC thresholds.

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Topics: SeraSeq, NGS reference materials, Clinical NGS Assays

Sensitive ctDNA Assays are Required for Minimal Residual Cancer Detection

Posted by Russell Garlick on May 29, 2018 3:10:00 PM

The 11th International Symposium on Minimal Residual Cancer was held this month and much of the conference was devoted to new minimally invasive methods for circulating tumor cell enrichment and or the analysis of circulating tumor DNA. Today’s clinical needs are to measure disease burden, track mutations over time, or to detect early resistance and all of these applications require extremely sensitive, robust assays.

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Topics: ctDNA, SeraSeq, DNA