Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | NGS | Molecular & Serology

Russell Garlick, PhD

Recent Posts

The Promise of Liquid Biopsy: A Q&A with Dr. Claudia Vollbrecht

Category: NGS, ctDNA, cfDNA, reference materials, ccfDNA

Posted by Andrew Anfora, PhD on Mar 24, 2021
  This is Part 3 in a 3-part Q&A blog series with a panel of liquid biopsy experts addressing many of the issues faced in developing and deploying NGS-based liquid biopsy assays for clinical applications in oncology. At a 2020 liquid biopsy webinar, Dr. Vollbrecht shared a molecular pathologist’s perspective on the current state of liquid biopsy. Laboratory processing and analysis of cfDNA samples is a multi-step process that requires a high degree of precision to achieve consistent results. Her presentation focused on pre-analytics variables, which are often left out of discussions and tend to focus on biochemical manipulation of isolated nucleic acids. Seemingly simple factors at the point of sample collection such as problems with blood test tube filling, storage and labelling are able to affect the cfDNA stability, abundance, and confound the reliability of final interpretation. Variation in sample treatment during laboratory processing, including but not limited to, cfDNA quantification and QC methodology are also amongst the challenges for liquid biopsy.
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The Promise of Liquid Biopsy: A Q&A with Professor Ed Schuuring

Category: NGS, ctDNA, cfDNA, reference materials, ccfDNA

Posted by Krystyna Nahlik, PhD on Mar 10, 2021
  This is Part 2 in a 3-part Q&A with a panel of liquid biopsy experts addressing many of the issues faced in developing and deploying NGS-based liquid biopsy assays for clinical applications in oncology. At a 2020 liquid biopsy webinar, Professor Schuuring discussed the plethora of options available to detect low copy number mutations in plasma cfDNA of lung cancer patients. His research laboratory combines NGS, ddPCR, qPCR and mass spectrometry approaches to address three main applications: (1) primary diagnosis by detection of predictive mutations, (2) monitoring of treatment response based on changes in plasma mutant levels, and (3) detection of therapy resistance mechanisms.
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The Promise of Liquid Biopsy: A Q&A with Professor Sandi Deans

Category: NGS, ctDNA, cfDNA, reference materials, ccfDNA

Posted by Krystyna Nahlik, PhD on Mar 4, 2021
  This is Part 1 in a 3- series deep-dive Q&A with expert panelists addressing many of the issues faced in developing and deploying NGS-based liquid biopsy assays for clinical applications in oncology. At the 2020 liquid biopsy webinar, Professor Sandi Deans highlighted a recent EQA scheme aimed at evaluating the standard of cfDNA testing in NSCLS and CRC patients. It was driven by demand from participants themselves, as well as pharmaceutical companies, IVD manufacturers and IQNPath (International Quality Network for Pathology).
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The Promise of Liquid Biopsy for Cancer Diagnostics and Therapeutic Monitoring: Are We There Yet?

Category: NGS, ctDNA, cfDNA, reference materials, ccfDNA

Posted by Krystyna Nahlik, PhD on Feb 25, 2021
This is the introduction to a 3-part Q&A with a panel of liquid biopsy experts addressing some of the issues faced in developing and deploying NGS-based liquid biopsy assays for clinical applications in oncology. In this 3-part blog series, we will share highlights from a recent Liquid Biopsy Expert Panel webinar sponsored by LGC Seracare and facilitated by GenomeWeb, which brought together academic research and clinical experts in liquid biopsy technologies to discuss the benefits, shortcomings, challenges and recommendations for liquid biopsy adoption in the context of cancer disease management. The webinar drew a lot of interest and sparked in-depth questions from attendees, which required a post webinar follow-up response from all 3 panelists.
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Challenges of Preimplantation Genetic Testing

Category: NGS, New Reference Material, Women's health, Reproductive Health, PGT, PGT-A, PGS

Posted by Agnes Caruso,PhD on Dec 15, 2020
Getting pregnant is not always simple and with an increase in the age of first-time mothers, there is an increased need for in vitro fertilization (IVF). IVF allows the generation of embryos in the lab and subsequent embryo transfer to the patient. Successful implantation of the embryo depends on many factors with chromosomal aneuploidy being one of the important factors in a failed IVF cycle. There are several ways the odds of success can be increased and risks of miscarriage are reduced.
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Key Strategies for Reducing Turnaround Time in Your Clinical Lab

Category: Molecular & Serology

Posted by Eric Morreale, PhD on Mar 3, 2020 9:00:00 AM
  They say good things come to those who wait, but when it comes to laboratory testing, faster is almost always better (assuming, of course, that accuracy is never compromised). The more rapidly that reportable results are generated, the quicker clinicians and patients can make decisions and embark on an effective treatment program. Furthermore, the more efficiently labs can run tests and generate results, the more they can accomplish. Faster turnaround times (TAT) can free up staff and resources for other activities, like growing the overall test menu. And let’s not forget the reputation factor. Labs want to be the reliable go-to for the clinicians they serve. They want to be trusted for their accuracy, professionalism, and speed.
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Is Your Lab Struggling with Burnout Like Other Labs? Here's How Reference Materials May Help.

Posted by Eric Morreale, PhD on Feb 25, 2020 9:00:00 AM
  A staffing crisis may be looming in the nation’s clinical testing laboratories, and many labs are already facing the problem. Labs are understaffed, while the demand for clinical testing is only going up. Turnover is high among lab technicians, as burnout and job dissatisfaction leads them to seek employment elsewhere or abandon their lab tech careers altogether. For lab directors, frequent turnover, diminished staffing, and employee unhappiness are vexing issues. A staff of motivated, qualified, and experienced technicians is one of the keys to generating the high volume of accurate, reportable results clinicians and healthcare organizations demand. How can you hold on to your best technicians while getting your newest team members up to the same skill level quickly? As we’ll see, an efficient and effective training program is essential. Well-trained technicians are more likely to stay in their jobs. New technicians perform at a higher level sooner when their labs prepare them for the variations they’ll encounter when working with real patient samples.
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4 Best Practices for QC in a Clinical Testing Lab to Ensure Accurate Results

Category: Molecular & Serology

Posted by Eric Morreale, PhD on Feb 18, 2020 9:00:00 AM
  What is a clinical laboratory director’s worst nightmare? That’s an easy one. The thought that, somehow, an inaccurate testing result has escaped their lab and convinced an unsuspecting clinician to make a poor patient care decision. So much of modern medical care is grounded in treatment decisions based on diagnostic testing results. According to one review of the data, 98 percent of in-patient populations get lab tests. False negatives can delay life-saving and life-improving patient care. False positives can cause patients to undergo unnecessary treatment, which can result in needless psychological, physical, and financial distress. No wonder lab directors are troubled by the possibility, no matter how small, of reporting inaccurate results - critical patient care decisions hang in the balance. (Not to mention the professional reputations of lab directors, the reputations of their labs and hospitals, and the trust of patients and clinicians.) To prevent errors in testing and reporting, quality control is a must. You need to be confident every time you report a result that your assays are working the way they are intended. Here are four tips for optimizing quality control to ensure accurate results in your clinical lab:
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How to Comply With CLIA and Pass PT With Ease

Posted by Eric Morreale, PhD on Feb 11, 2020 9:00:00 AM
  Proficiency testing under CLIA is no joke. Failed tests lead to costly downtime for equipment and personnel as labs troubleshoot to find the source of an error. In the case of proficiency testing (PT), failures lead to time invested in corrective-action measures, and in the worst case, cease-testing directives from regulatory authorities. A failed CLIA proficiency test — multiple failures, especially — is the ultimate black mark not only on the career of a lab director but on the reputation of a clinical lab.  The key to CLIA confidence is the same simple approach you took to ace your exams back in college: preparation. If you run your assays through their paces on a regular basis, and you use high-quality third-party controls to root out any weak points in your testing protocol and train your lab staff, CLIA proficiency testing will be a breeze.
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For Clinical Labs: Avoid False-Positives and Negatives by Being a Control Freak

Category: M&S

Posted by Eric Morreale, PhD 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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