“Researchers at City of Hope question the reliability and utility of Natera’s Signatera, highlighting the results as evidence that genomic minimal residual disease (MRD) testing may be at BEST unhelpful and at WORST unreliable in detecting recurrences earlier than the standard-of-care imaging and blood protein tests.”*
“Based on this, investigators calculated that the combination of imaging and CEA had better sensitivity (72 percent) than ctDNA (53 percent) in identifying disease recurrence in the cohort. They concluded overall that the results suggest that ctDNA assay provides “no definitive advantage” over the NCCN recommended standard of care.”*
Genetic and genomic testing is NOT regulated by the FDA. Whether your patients or loved ones are being tested for cancer, prenatal testing, rare diseases, etc., a Laboratory Developed Test (LDT), which 99% of genetic and genomic tests are today, are NOT being evaluated for accurate results or clinical utility.
How is a healthcare provider, insurance payer, or patient supposed to know if the genetic and genomic testing labs are providing accurate data on outcome and results?
Center for Genomic Interpretation can assist you in understanding if the lab you have chosen to order or reimburse is providing accurate results, as well as if their marketing message aligns to their actual test offering! Elevate Genetics
Call today to learn more about how CGI can help you, your organization and your patients! (801) 810-4097. Please email:
firstname.lastname@example.org to sign up for our newsletter. Stay up to date with the quickly changing genetic and genomic testing space!
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*Natera Minimal Residual Disease Test Value Called Into Question by City of Hope CRC Patient Data | Precision Oncology News Mar 9, 2022
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.
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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.