Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

Choose your Article Focus | NGS | Molecular & Serology

Sam Blier

Recent Posts

Advancing Immuno-Oncology Biomarker Validation with Industry’s First NGS-based TMB Reference Materials

Category: NGS, Immuno-Oncology

Posted by Omo Clement, PhD on Sep 2, 2020
Overview Tumor mutational burden (TMB) is a measurement of the number of mutations carried by a tumor cell genome. By comparing DNA sequences from a patient’s healthy tissue and tumor cells, and using a number of complex algorithms, scientists can determine the number of acquired somatic mutations present in tumors but not in normal tissues.1 NGS is the primary method employed to measure TMB, either through targeted panels or whole exome sequencing (WES);2 the latter is considered the gold-standard measurement today.
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Highlights from the ESHG and ESHRE 2020 Virtual Conferences

Category: NGS, NIPT, Women's health, Reproductive Health, Non-invasive Prenatal Testing, PGT, Preimplantation genetic testing

Posted by Agnes Caruso on Aug 20, 2020
The plans for this year’s NIPT and PGT conferences, like many others, were quickly derailed by the COVID-19 pandemic. The ESHG and ESHRE Annual Meetings were moved to virtual space and even though the format was a new experience, the science did not disappoint. Here we will share some of the highlights from the sessions.
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Design and Development of Compromised FFPE Reference Materials

Category: NGS

Posted by Dana Ruminski Lowe, Ph.D. on Aug 11, 2020
    Tumor profiling assay workflows start from a tissue biopsy sample that is formalin fixed and paraffin embedded (FFPE), a process that introduces various kinds of damage in the nucleic acids in the tissue specimen. Reference materials that closely mimic the damage profile of patient FFPE samples are lacking. Depurination, depyrimidination, deamination, oxidation, nicks, and double strand breaks may be found in DNA extracted from FFPE tissue, despite the use of extraction kits that attempt to repair some of this damage. We have developed a formalin-damaged, multiplexed biosynthetic reference material, Seraseq® Compromised FFPE Tumor DNA, as well as a companion wild-type (WT) material, Seraseq Compromised FFPE WT, to mimic the damage found in patient samples that can be used to assess the entire tumor profiling workflow. We compared the performance of these reference materials in downstream assays to that of FFPE material with minimal DNA damage such as the Seraseq FFPE WT (DNA/RNA) RM product.
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Supporting High-Quality Testing for Women’s Health

Category: NIPT, Breast Cancer, Reproductive Health, Non-invasive Prenatal Testing, HIV

Posted by Agnes Caruso on May 15, 2020
This week is National Women’s Health week1 and is dedicated to women to focus on their health and take steps to improve it. As Women’s Health week traditionally starts on Mother’s Day, we tend to focus primarily on Reproductive Health but it is important to look at the complete picture as some women encounter various conditions and treatments prior to starting a family. Women’s health encompasses things like fertility, pregnancy, infections, cancer, but also many underlying health conditions such as hypertension, diabetes, cardiovascular or respiratory conditions. Many of women’s health problems can be diagnosed by using advanced testing methods. As the technology develops and becomes more complex, ensuring the best performance of the tests is even more critical. With better testing, it is possible to improve outcomes for women around the world.
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Do COVID-19 infections affect NIPT?

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

Posted by Prof. Joris Vermeesch, PhD on Mar 26, 2020
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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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
 
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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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