Getting the NGS wet bench process right is not a small undertaking. Targeted NGS assays such as multigene panels or exome sequencing allow for the targeted analysis of genomic regions that are of particular interest. For every sample type, e.g. blood, formalin-fixed paraffin-embedded specimens, saliva etc, there must be a detailed protocol in place outlining how each sample type is going to be handled. The laboratory has to define and document clear and crisp criteria for the wet bench process summarized in a quality management program.
An acceptable quality assurance (QA) program has the following characteristics:
The quality assurance program outlines the specific steps of each workflow performed in the lab.
If the lab is part of a larger institution such as a hospital or medical center, then the quality assurance program for the lab needs to be integrated with the QA program of the larger organization.
The program should outline how to handle any outliers and respectively any problems that typically arise executing the workflow. It should also outline possible corrective actions, as well as the dismissal of a sample.
The QA program needs to ensure that the testing is for clinical purposes and the results of the tests need to be in sync with current medical science.
The program needs to outline how employees can voice any concerns about the work conducted in the lab.
Part of being an evolving set of technologies means that NGS doesn’t provide perfect results. It’s widely accepted that NGS-based sequencing assays will yield false-positive, as well as false-negative results. It’s the proverbial nature of the beast….
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Dr. Andreas Scherer is CEO of Golden Helix. The company has been delivering industry leading bioinformatics solutions for the advancement of life science research and translational medicine for over a decade. Its innovative technologies and analytic services empower scientists and healthcare professionals at all levels to derive meaning from the rapidly increasing volumes of genomic data produced from next-generation sequencing. With its solutions, hundreds of the world’s hospitals and testing labs are able to harness the full potential of genomics to identify the cause of disease, develop genomic diagnostics, and advance the quest for personalized medicine. Golden Helix products and services have been cited in thousands of peer-reviewed publications. Golden Helix is also on the Inc 5000 list of the fastest-growing private companies in the US.
He is also Managing Partner of Salto Partners, Inc, a management consulting firm headquartered in Nevada. He has extensive experience successfully managing growth as well as orchestrating complex turnaround situations. His company, Salto Partners, advises on business strategy, financing, sales, and operations. Clients are operating in the high-tech and life sciences space.
Dr. Scherer holds a Ph.D. in computer science from the University of Hagen, Germany, and a Master of Computer Science from the University of Dortmund, Germany. He is author and co- author of over 20 international publications and has written books on project management, the Internet, and artificial intelligence. His latest book, “Be Fast Or Be Gone”, is a prizewinner in the 2012 Eric Hoffer Book Awards competition, and has been named a finalist in the 2012 Next Generation Indie Book Awards!
