“Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.” – The National Institutes of Health https://lnkd.in/gcRf3Hg6.
Most Precision Medicine is guided by genetic or genomic tests, which may or may not be reliably accurate depending upon which Clinical Laboratory runs the test!!! There is no standardization for laboratory developed testing labs to report their performance, so comparing lab-measured sensitivity and specificity is useless. So how can Health Insurance Payers and Self Funded Employers make sure that their plan members receive accurate genetic/genomic testing if regulators aren’t yet verifying most Clinical Genetic and Genomic laboratory developed tests? They can either reimburse only FDA Approved Companion Diagnostic (CDx) tests when available https://lnkd.in/giz-9wuk (recommended by CGI), and/or require that Clinical Genetics and Genomics laboratories have at least their premier diagnostic tests third party and independently assessed for accuracy and validity through our nonprofit’s ELEVATEGENETICS services. See https://lnkd.in/eGcd_sqV.
CLIA and CAP accreditations are mostly at the laboratory level, and are insufficient to determine if all/most of a labs’ tests are accurate. The passing bar is VERY low for CLIA/CAP proficiency testing. Labs need only get 80% accuracy in CLIA/CAP proficiency testing to get the same accreditation from CLIA and CAP that labs clearing the accuracy bar with 99.9% get. Additionally, the CLIA/CAP proficiency testing is known to be too easy and does not represent the true spirit of proficiency testing https://lnkd.in/gxxaeCkG. So the low bar of CLIA/CAP accreditation does not allow Payers, Clinicians, or Patients to choose the most accurate labs for their testing. Payors are frequently paying top dollar for tests that are less accurate than less expensive tests. False positive and false negative genetic/genomic test results are harmful to patients and cost payers more money in the long run. ELEVATEGENETICS services are currently the only services out there that can help Payers discover which laboratory developed genetic and genomic tests are the most accurate and clinically valid. See https://lnkd.in/eGcd_sqV. We hope that the demand for comparative accuracy assessment services becomes so great that others can join us in providing these services. As for now, we’re the only ones here in the USA.
Follow this link to learn more about the accuracy and validity problems in laboratory developed genetic and genomic tests: https://lnkd.in/eJnVuucS