SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, has partnered with GenomeWeb to conduct a first-of-its-kind survey for clinical NGS labs with over 150 respondents providing comprehensive data detailing their QC management programs.

“The largest problem in the state of clinical NGS testing today is the lack of standardisation and this survey shows that there is room for improvement across the board,” said Dr. Gregory Tsongalis, Director of the Laboratory for Clinical Genomics and Advanced Technology at Dartmouth Hitchcock Medical Center. “I’ve never seen anything in my career where there are so many options on how to do testing. All of the choices in instruments and assays may explain the lack of standardisation but it is important for labs to increase their use of appropriate materials, tools, and fully align with the guidelines published by organizations such as CAP and AMP.”

According to the survey results, there is a significant opportunity for labs to implement NGS standardization of QC solutions designed to improve quality. SeraCare is addressing this opportunity by combining the power of the Seraseq line of manufactured reference materials designed for NGS applications and iQ NGS QC Management software.

Another critical finding from the survey is that two-thirds of respondents currently use homebrew and Excel or custom developed data management solutions. Without frequently running GMP manufactured materials and collecting and trending data with a robust data management program, it is impractical to benchmark and identify drift in performance longitudinally and across labs.

Troubleshooting runs appears a major pain point for respondents and could stem from the lack of standardisation. Critically, this troubleshooting time has potential impacts for patients. Dr. Tsongalis states “the fact that 50% of respondents are having QC stops at least once per month and taking at least one day to troubleshoot is higher than I expected and could have an impact on the management strategy for the patient by delaying reporting.”

Dr. Tsongalis concludes that “more than half of respondents expressed a desire to troubleshoot more quickly. By standardising their QC management system by incorporating the recently published guidelines and adopting more comparable and appropriate materials and tools, I believe labs will both have less runs to troubleshoot and troubleshoot more quickly.”

Read the survey report and see the response data here.


Materials were provided by SeraCare Life Sciences and may have been edited for length. 

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