February 2022 – The Data Driven Point of View Newsletter. Laboratory Developed Test (LDT) vs. FDA-Approved Companion Diagnostic (CDx)

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!

truth-in-genomics@genomicinterpretation.org

Please click below for the full newsletter and associated reference article: February 2022 Data Driven Point of View Newsletter Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics; John D. Pfeifer. Dec. 2021. ASCP. For more information about CGI, see www.genomicinterpretation.org.  CGI is offering several unique ELEVATEGENETICS programs that establish meaningful and actionable pathways to improve genetic/genomic testing, analysis and reporting. For payers, ELEVATEGENETICS metrics offer unique evaluations when selecting and contracting with laboratories.  For laboratories, these programs offer a unique third-party review focusing on key aspects of the genetic/genomic testing process which can dramatically improve the accuracy of test findings.  For providers and consumers, CGI offers a number of resources to better understand the complex landscape of precision medicine. # # #   The Center for Genomic Interpretation – www.genomicinterpretation.org The Center for Genomic Interpretation (CGI) is an independent 501(c)(3) nonprofit organization with the mission to save and improve lives through encouraging careful stewardship of clinical genetics, genomics and precision medicine. Too frequently the precision medicine goals of patients and their providers are unknowingly thwarted by inaccurate or ineffective genetic or genomic testing. We facilitate the realization of value from among the confusing scramble of the new precision medicine era. The CGI team consists of clinical genetics and genomics scientific leaders, healthcare policy veterans, experienced business professionals, and others dedicated to helping stakeholders achieve the vision and promise of precision medicine.  CGI offers a range of programs and services targeted to all stakeholders including patients, providers, payers, pharmaceutical developers, policy makers and laboratories.