April 2022 – The Data Driven Point of View Newsletter. FDA Oversight Needed So Lab Tests Do More GOOD than HARM

Apr 1, 2022 | News

————— Have you heard of the VALID Act and understand how it would drastically improve the quality of care provided to patients? Laboratory Developed Tests have never been regulated by the FDA. That’s why our nonprofit has to help payers sort through which genetic/genomic tests have clinical value and provide accurate results, and which do not. Insufficient regulation has provided the perfect environment for fraud, waste and abuse. If the VALID Act passes, the FDA would finally have authority to regulate these wild-west clinical tests. Please study the issue, and if your organization supports FDA oversight of clinical diagnostics, like our nonprofit organization does, please let congress know. Here is a copy of the VALID Act: https://www.congress.gov/bill/117th-congress/senate-bill/2209/text
CGI supports ACCURATE lab results that drive CORRECT patient care.
Problem:  Inaccuracies in Laboratory Developed Tests (LDTs) continue to impact patient care, which has also led to recent class action lawsuits.  CLIA and CAP approvals are NOT enough, as accuracy is NOT sufficiently evaluated! 
Is the genomic test you order or cover as a ‘preferred’ test resulting in an accurate result?  
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 April Data Driven Point of View newsletter, which will provide 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 us today to set up a time to learn more and start the analysis of your ¨preferred¨ comprehensive genomic profiling labs.
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Please click below for the full newsletter: April 2022 Data Driven Point of View Newsletter 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 Interpretationwww.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.