A Panel of Experts Discusses Best Practices for Clinical NGS Quality Management in the Rapidly Evolving Field of Clinical Genomics
A consortium of industry experts has combined forces to solve TMB challenges.
Introducing the SeraCare Confidence Score, a comprehensive precision metric designed for NGS assays
Use genetic information to treat, or at least to diagnose and to predict
We’ve already covered the first two steps. In this article, we’ll look at the third one. Choosing the right reference material technology can help control the high validation and running costs of highly multiplexed assays.
Because NGS assays are so complex, involving a dizzying number of genes, mutation types, and options for sequencing and bioinformatics, the bulletproof assay is no easy feat. But it can be done.
Evaluate your detection of key diagnostic, prognostic, and therapeutic markers
What do we mean by bulletproof? A bulletproof NGS assay is one that exhibits the highest performance and reliability in delivering patient results. If you want every assay your lab develops to be bulletproof, read on.
Critical missteps during the assay development phase can cause expensive delays and risk the quality of an assay. How can you be sure your bioinformatics pipeline is correctly calling variants?
From extraction, to library prep, to sequencing, to the bioinformatics pipeline, there are countless points where something could go wrong.
Session Summary from Next Generation Dx Summit 2017
SeraCare’s new Seraseq™ Circulating Tumor Reference Materials
Insight from the 2017 Precision Medicine World Conference
iQ™ NGS QC Management software for easy assessment of assay performance
The Chair of Molecular Diagnostics, Department of Pathology at Virginia Commonwealth University shares her success story
A 0.1% measurement requires a reasonable amount of input material
How do I know my NGS-based LDT is producing the right results? And how do my results compare with others running similar tests?
From troublesome mutations to FDA validation studies
For clinical genomics testing laboratories, validation — and to a certain extent, revalidation — is a fact of life.
Robust molecular and serology reference materials for Zika diagnostic assays
Do remnant patient samples perform well enough to train new laboratory personnel quickly and assess their proficiency?
Daily variations in your test performance can cause assay failure and may lead to false positives. Do you have the tools to detect them?
Patients Can't Afford to Wait for Their Test Results
Answering frequently asked questions (FAQs)
Status of FDA regulation of laboratory developed tests, the promise of precision medicine, and a workshop about achieving accurate NGS laboratory test results
Seraseq FFPE Tumor KRAS Reference Material Kit
A Journal for Molecular Diagnostics article describing ‘an attractive addition to the repertoire of materials for the development, validation, and quality monitoring of clinical NGS assays’
"The most effective ways to use QC data to monitor the health of your NGS assay."
“Ensure NGS-based tests for Personalized Medicine are safe and effective for guiding medical management decisions”
The distinction between accuracy and precision.
Important information for assay development and review by the FDA
Her vision of genomic medicine as a dialogue at ESHG 2016 in Barcelona, Spain
Recombinant viral technology to assist development of PCR-based Zika Virus diagnostic assays
Circulating tumor DNA, along with immunotherapy, are two major themes of #AACR16
The premier cancer research conference heads to the New Orleans Convention Center April 17 - 20, 2016
Impressions from the first FDA workshop focusing on NGS-based oncology diagnostic tests
The Seraseq Circulating Tumor DNA-I Reference Materials officially launches, as well as a Circulating Tumor DNA-I Mutation Mix
Diagnosing inherited disease, processing FFPE samples, state-of-the-art oncology in North Carolina, and developments in circulating tumor DNA technology
A molecular medicine, drug discovery and diagnostics conference recognizing the potential of new technologies and their role in mitigating disease and identifying transformative treatments
A webinar co-sponsored by TOMA Biosciences, Intermountain Health and SeraCare
Poster Titled “New Technical Approach to Construct ctDNA Materials for use in Characterizing, Developing and Validating Plasma Assays”, available for download
Performance analysis of SeraCare’s Seraseq Solid Tumor Mutation Mix-I AF10 and AF20
Recent NCI publication for validation of a targeted NGS assay for treatment assignment in the NCI-MPACT trial
Counterpoint to the FDA arguments for laboratory-developed test oversight
Three major themes in 2015 from SeraCare
Laboratory-developed tests are in the spotlight by the US Food and Drug Administration
A handy infographic to compare the first-generation (Sanger) and next-generation sequencing (NGS) technologies
A personal story of an expectant father intersects with the complex problem of testing specificity and sensitivity
Interview with Dr. Seth Harkins, Principal R&D Scientist
A brief review of fetal aneuploidy testing
Two presentations of note from the 2015 AMP Conference, Austin Texas #AMP2015
The 2015 Association for Molecular Pathology (Austin TX) posters about Reference material stabilization technology, recombinant virus, fetal trisomy patient-like material, and somatic tumor mutation profiling.
How can you measure something without a ruler?
With the theme "Realizing the Promise of Precision Medicine" in Austin, Texas
Interview with Dr. Greg Tsongalis, Professor of Pathology, Dartmouth-Hitchcock Medical Center
Recent publication highlights potential of personalized medicine for young cancer patients
Interview with Condie Carmack, Ph.D. Vice President Translational Medicine, GenomOncology
Are you wondering why reference materials are needed for precision medicine?
SeraCare, Precision Medicine and You