January 2022 – The Data Driven Point of View Newsletter. No FDA Regulation Exists for Prenatal Genetic Testing

Jan 5, 2022 | News

Does transparency and truthful marketing exist for the labs you have chosen as ¨preferred¨ for your prenatal genetic testing?  The New York Times recently published an article discussing how little regulation exists for prenatal testing for patients. This potential for misrepresented test results is potentially life changing for your covered members, as well as a large cost to your spending. Problem:  NO FDA Regulation Exists for Prenatal Genetic Testing = Potentially Misleading Marketing Materials, Claims, and False Positive results for your insured members or patients you treat. Solution:  Center for Genomic Interpretation (CGI) can assist by reviewing provided marketing materials to ensure the tests are being accurately represented.  The actual lab data should also align.  Let us analyze this quickly and inexpensively today! Please take the time to read through the attached 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¨ prenatal genetic testing labs.   Please email us if you would like to be added to the monthly email newsletter list!


Please click below for the full newsletter: Jan 2022_CGI’s Data Point of View Newletter_Lack of Regulation and Low Accuracy of Prenatal Genetic Testing NIPT NY Times (1) 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.