Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | NGS | Molecular & Serology

Ram Santhanam

Recent Posts

For Clinical Labs: Avoid False-Positives and Negatives by Being a Control Freak

Catagory: M&S

Posted by Eric Morreale on Nov 26, 2019 12:00:00 PM
Do you consider yourself a control freak? And by control, we mean quality control - the procedures and materials implemented to ensure test accuracy and precision. Most importantly, having the proper controls in place provides confidence in the accuracy of your tests and the reported results, reducing the risk of generating false-positives or false-negatives. A strong quality program has the added benefits of reducing both the amount of valuable staff time expended on troubleshooting, as well as costly instrument and assay downtime.
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How Third-Party Controls Can Help Keep Your Clinical Lab Within Budget (Without Sacrificing Quality)

Catagory: M&S

Posted by Eric Morreale on Nov 19, 2019 12:00:00 PM
As a clinical lab director, you are driven by two forces which, at first glance, may seem in opposition to each other. The first is your commitment to delivering accurate diagnostic test results to healthcare providers, a responsibility critical to ensuring that patients receive the most effective and timely treatment possible. In your lab, this means instituting a strong quality control (QC) program aimed at ensuring test performance and preventing the release of inaccurate results. The second driving force is the responsibility you have towards to running an efficient, cost-effective clinical lab operation. This entails the responsibility to manage resources efficiently, to stay within allotted budget guidelines, and to avoid unnecessary spending. The obvious assumption is that higher quality translates into higher costs (and bigger budgets). Look closer, however, and you’ll discover that the two forces outlined above are not necessarily opposed. As you’ll see below, increasing accuracy and reliability in a clinical testing lab — through investment in additional QC measures, such as high-quality third-party controls — can actually translate into decreasing costs. Staying within budget and providing reliable results can go hand in hand.
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3 Tips for Reducing Test Repeats and Lab Downtime

Catagory: M&S

Posted by Eric Morreale on Nov 12, 2019 12:00:00 PM
The world of a clinical testing lab is one of high pressure. The pressure comes from clinicians who want their results as quickly as possible. It comes from directors and managers who demand efficiency. And most of all, it comes from a constant stream of samples that never lets up. In this era of largely automated instrumentation (operating almost always at full capacity), few things are more frustrating to lab personnel than errors that result in downtime, troubleshooting, and the need to rerun tests. Reportable results is the most important metric in a clinical lab. Any result that is not reportable translates into higher costs, more downtime, and a growing backlog. What can you do to reduce momentum-killing test failures and repeats while increasing your reportable result rates?
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For Clinical Labs: How to Ensure a Consistent Supply of High Quality Reference Materials

Catagory: M&S

Posted by Eric Morreale on Oct 29, 2019 12:00:00 PM
Healthcare is — to put it mildly — unpredictable. You never know when testing demands will change due to a disease outbreak, or a shift in medical consensus. Thus, clinical labs operate with a basic mindset: be prepared.
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So Many Posters, So Little Time

Catagory: ctDNA, AACR, RNA fusion, TMB

Posted by Sam Blier on Jun 6, 2019 10:32:00 AM
Cancer research is purposely methodical and measured. So – somewhat paradoxically – it can be difficult to keep up with the steady stream of discoveries in the literature and presented at conferences like AACR. As a developer and manufacturer of platform-agnostic NGS reference standards, we’re in a unique position to collaborate with cancer genomics assay developers, laboratories, pharmaceutical companies, and other organizations invested in more precise and robust cancer tests.
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Newly Published Multi-Laboratory Study Provides Utility and Validation of the Use of ctDNA Reference Standards

Catagory: ctDNA, cfDNA

Posted by Russell Garlick on May 30, 2019 3:32:00 PM
I am pleased to share findings from a newly published peer-reviewed study with foundational circulating tumor DNA (ctDNA) pre-analytical and analytical testing in multiple technologies and assay chemistries. The study, “Multi-laboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements,” was just published in The Journal of Molecular Diagnostics (He, Stein et al. 2019).
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Making the Shift from Technological Innovation to Operational Excellence: Delivering on the Promise Of Next-Generation Sequencing for Personalized Medicine

Catagory: NGS, clinical genomics

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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Precision Medicine and Clinical Labs: AACR Dinner Seminar Recap

Catagory: clinical genomics, cfDNA, AACR

Posted by Trevor Brown on Apr 15, 2019 10:30:00 AM
One of the core aims of precision medicine is to provide a more tailored approach to disease diagnosis, therapy selection, and patient monitoring to improve the overall quality of life for patients with disease. Indeed, this aim has been at the heart of the high interest and study of the potential of liquid biopsies to improve patient care in earlier detection of cancer, treatment, and surveillance.
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Presenting NTRK Reference Materials for Global Assay Standardization at AACR 2019

Catagory: SeraSeq, AACR, NTRK, RNA fusion

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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cccDNA and HBV:  New Testing Methods May Allow for Earlier, Non-Invasive Detection of Hepatocellular Carcinoma

Catagory: Accuplex, Molecular & Serology

Posted by Catherine Huang on Aug 23, 2018 12:00:00 PM
A recent study, published in the Journal of Molecular Diagnostics, describes a new, more sensitive Hepatitis B Virus (HBV) assay1.  This study, led by Song-Mei Liu, MD, PhD, of the Center for Gene Diagnosis, Zhongnan Hospital of Wuhan University in China, is particularly exciting because the new assay can be used to diagnose hepatocellular carcinoma (HCC) at an earlier stage and to manage antiviral HBV treatments more effectively. It also highlights the way innovative molecular diagnostics can play a synergistic role with the development of new pharmaceutical therapeutics.
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