Genomic Precision

 A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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

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

Next-Generation QC Precision Metrics for Next-Generation Sequencing

Introducing the SeraCare Confidence Score, a comprehensive precision metric designed for NGS assays

Posted by Lorn Davis on Apr 16, 2018 4:00:00 PM

Introduction

There is an even greater onus to track quality control metrics for NGS assays because of the number of steps and elements that must successfully work together to produce consistent results. The Standards and Guidelines for Validating NGS Bioinformatics, published in January by AMP and CAP, highlight the importance of tracking QC metrics over time because “trends in these metrics can indicate an emerging issue with an NGS process that has not yet manifested itself in failed tests.”

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Topics: NGS, QC Challenges, NGS Management Software, QC Management Software, bioinformatics, Quality Management Systems, qc management

What Is The Difference Between Quality Control Software Like iQ NGS And LIMS?

Posted by Lorn Davis on Apr 6, 2018 8:00:00 AM

SeraCare Life Sciences, in partnership with GenomeWeb, recently offered this exciting on-demand webinar: 

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

3 Steps for Building a Bulletproof Clinical NGS Assay: Step 3

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.

Posted by Russell Garlick on Dec 8, 2017 10:30:00 AM

What does it mean for an NGS assay to be bulletproof and why does your lab need it?

In two previous blog articles (parts one and two), we’ve talked about the factors that go into making NGS assays that doctors can rely on to deliver targeted, lifesaving therapies to their patients. Bulletproof assays are the tests that make your lab a trusted name in the NGS field, a leader in a rapidly-growing market.

But, as we’ve written, genetic sequencing is complex, expensive, and time-consuming. Therefore, finding ways to do it more efficiently, while maintaining the quality of your tests, is in the best interests of your lab and its customers.

As a refresher, here are the three steps for building a bulletproof clinical NGS assay:

  1. Consulting with experts
  2. Outlining your validation and quality control (QC) strategies together
  3. Evaluating reference material options

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.

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Topics: NGS, qc management, RNA fusion

Is Your NGS-Based Assay on the Right TRK?

From extraction, to library prep, to sequencing, to the bioinformatics pipeline, there are countless points where something could go wrong.

Posted by Trevor Brown on Oct 9, 2017 2:13:00 PM

Despite the absence of clear guidelines or firmly established best practices, next-generation sequencing (NGS) assays are becoming the method of choice for gene fusion detection.

This is significant because, although some of the cancers that contain fusion RNAs are rare, they’re now treatable thanks to new targeted therapies. If your assay can detect fusion RNAs, it can help profile tumors for important diagnostic, prognostic, and therapeutic targets, which can lead to improved patient outcomes.

The old FISH method limited you to one type of fusion variant at a time; it was effective, but also slow and cumbersome. With the latest NGS techniques, detecting fusion RNAs is more efficient than ever. It’s more sensitive and can detect multiple fusions in the same assay.

Nevertheless, it’s still challenging because of the complex workflows and the need to rigorously ensure performance across all fusion variants. From extraction, to library prep, to sequencing, to the bioinformatics pipeline, there are countless points where something could go wrong.

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Topics: NGS, QC Management Software, qc management, reference materials, RNA fusion