The Medical Device Innovation Consortium (MDIC) is launching a new initiative testing somatic (tissue) reference samples to improve validation, as well as the regulatory review process for cancer diagnostic testing based on next generation sequencing (NGS). This will be done with the #FDA, #NIH, and #NIST. The goal is to create better public policy. See the full article from GenomeWeb HERE.
CGI is supportive and enthusiastic of all quality initiatives in clinical genetics and genomics and this is a good step forward. It’s not a complete solution and runs the risk of labs thinking these are the only standards they’ll need to use to validate, but these will be a great addition to what labs need to do to fully validate their tests.
With little to no regulation on the accuracy of hereditary cancer genetic tests, as they are all Laboratory Developed Tests (LDTs) without FDA oversight, Center For Genomic Interpretation is here to help you ensure your chosen lab is delivering accurate results for your patients. Follow CGI on LinkedIn and visit our website https://www.genomicinterpretation.org/elevategenetics/ to learn more!