Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | NGS | Molecular & Serology

Prof. Joris Vermeesch, Ph.D.

Recent Posts

Do COVID-19 infections affect NIPT?

Catagory: NGS, NIPT, Non-invasive Prenatal Testing, SARS-CoV-2, COVID-19

Posted by Prof. Joris Vermeesch, Ph.D. on Mar 26, 2020 3:45:00 PM
We would like to present a guest blog from Prof. Joris Vermeesch, Ph.D. This blog originally posted on the Noninvasive Prenatal Testing Online Resource Page on the 17th March summarizes our current understanding of any possible interference of SARS-CoV-2 infection on the outcomes of NIPT testing.
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Assessing RNA Extraction with FFPE Fusion RNA Reference Materials

Catagory: NGS, reference materials, RNA fusion

Posted by Dan Brudzewsky on Mar 11, 2020 12:00:00 PM
This is a third blog in a series on RNA fusions, this time focusing on how the FFPE Fusion RNA materials are used as RNA extraction controls.
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Key Strategies for Reducing Turnaround Time in Your Clinical Lab

Catagory: Molecular & Serology

Posted by Eric Morreale on Mar 3, 2020 9:00:00 AM
 
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Is Your Lab Struggling with Burnout Like Other Labs? Here's How Reference Materials May Help.

Posted by Eric Morreale 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

Catagory: Molecular & Serology

Posted by Eric Morreale 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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Diagnostic Testing Schemes for NTRK Cancers: All Roads Lead to NGS

Catagory: NGS, SeraSeq, NTRK, RNA fusion

Posted by Russell Garlick on Feb 12, 2020 12:13:31 PM
New treatment options for cancer patients with neurotrophic tyrosine kinase (NTRK) rearrangements are a tremendous success, demonstrating first-hand the importance of precision diagnostics. The FDA granted accelerated approval of Bayer's VITRAKVI (larotrectinib) for adult and pediatric solid tumors containing NTRK fusions1. The approval was one of the first tissue agnostic approvals based on genotyping results, and included patients with unresectable or metastatic cancer. For 12 cancer types, the overall response rate was 75% with 22% complete response and 53% partial response. In addition to VITRAKVI, Genentech's entrectinib has a "breakthrough" status and is being evaluated for the potential treatment of advanced or metastatic tumors that harbor NTRK or ROS1 gene rearrangements.
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How to Comply With CLIA and Pass PT With Ease

Posted by Eric Morreale 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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Evolution of non-invasive prenatal testing (NIPT) testing

Catagory: NGS, NIPT, #Quality, New Reference Material, reference materials, trisomy, Reproductive Health, Non-invasive Prenatal Testing

Posted by Agnes Caruso on Feb 5, 2020 11:45:00 AM
Prenatal screening for aneuploidy has changed dramatically since the 1970s. Non-invasive methods developed in the 1980s and 1990s, combined measurements of maternal serum analytes and ultrasonography. The problem with those methods was not just a high false-negative rate of 12% to 23%, a high positive rate of 5% and a poor sensitivity, ranging from 50% to 95% 1. Uncertain results frequently led to invasive procedures such as amniocentesis or chorionic villi sampling to perform karyotyping on fetal samples. Both of those procedures carry a risk of miscarriage.
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Multi-Lab Study of Fusion RNA Reference Standards for Targeted NGS

Catagory: NGS, reference materials, AACR, NTRK, RNA fusion

Posted by Andrew Anfora, PhD on Jan 28, 2020 11:45:00 AM
Sourcing assay validation samples as positive run controls or workflow controls in targeted NGS RNA fusion assays remains a challenge today. This is further exacerbated with clinical labs looking to provide validated NGS assays for patient stratification in a host of new drugs in clinical trials or newly approved targeting fusion genes, such as NTRK genes (Larotrectinib, Loxo/Bayer) and Entrectinib (Genentech/Roche) for rare cancers in adult and pediatric patients, and RET (Loxo/Lilly) for lung cancer. SeraCare produces several RNA fusion reference materials. This article describes the development and multi-laboratory evaluation of a pan-cancer multiplexed Fusion RNA reference standard for analysis of clinically relevant fusion genes in solid tumors. The evaluation was conducted at 5 different laboratories on different NGS platforms (amplicon- and hybridization capture-based) as well as at different RNA inputs within a platform. Results highlight the utility of this Fusion RNA reference material to support clinical NGS assays as positive controls in solid tumor cancer patient stratification for many of these fusion-based targeted therapies.
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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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