Is ACCURACY of a FDA-Approved Companion Diagnostic (CDx) SUPERIOR to a Laboratory Developed Test (LDT)? If you don’t know the answer (or even if you think you do), please read on! ————— Does a Laboratory Developed Test (LDT) identify ALL variants or mutations? How does that compare to a FDA-Approved Companion Diagnostic (CDx)? Does it matter for targeted therapy associations for patients? A recent article published in the American Journal of Clinical Pathology (AJCP) evaluates reference samples to compare Next Generation Sequencing (NGS) test performance for Oncology therapeutics and diagnostics. The conclusions are quite eye opening! “Variable accuracy” exists between the test offerings. Only 37% of laboratories correctly reported ALL variants! Problem: Head-to-Head studies have not been completed to evaluate if a LDT can identify as many clinically actionable alterations as a FDA-approved CDx. Laboratory Developed Tests are not evaluated by the FDA. How do you choose which tests to allow ‘in network’ for your members? Are your members receiving the right precision therapies? Solution: Center for Genomic Interpretation (CGI) can assist by taking a non-biased approach by reviewing ‘in-network’ testing options to ensure the tests are being accurately represented. Can the lab detect and report out the right variants and mutations? Let us analyze this quickly and inexpensively today! Our review of a lab test’s technical accuracy costs less than a single course of oncology precision therapy. Please take the time to read through the attached February Data Driven Point of View newsletter, which will provide you and/or your organization a solution to this issue. CGI can assist with this project, as well as with creating transparency with other ¨preferred¨ labs for multiple precision therapeutic areas, all of which are a large cost for potentially false positive, false negative or misleading results. Please contact CGI today to set up a time to learn more and start the analysis of your ¨preferred¨ comprehensive genomic profiling labs. Please email us if you would like to be added to the monthly email newsletter list!