“The [FDA] has become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA authorized tests. This may negatively impact treatment decisions.” – June 20th, 2023 FDA News Release. https://lnkd.in/gXvcdXAV

This week the Center for Genomic Interpretation educated many health insurance plan representatives about the fact that the vast majority of Laboratory Developed Tests from CLIA certified and CAP accredited labs have not proven their accuracy, safety, or effectiveness to any outside and independent third party. More than 99.9% of Clinical Genetic & Genomic tests guiding precision medicine are merely Laboratory Developed Tests rather than FDA approved tests, and therefore have not proven their accuracy to any outside rigorous third party. Most Clinical Genetic and Genomic tests are much less accurate than the FDA approved tests they claim to mimic or be better than (see publications on this page https://lnkd.in/eJnVuucS), but doctors are unaware of this problem. Unreliable clinical genetic & genomic biomarker tests issue too many false positives and false negative results, harming patients, confounding precision medicine, and wasting healthcare spend in ways doctors don’t realize. Certainly biomarker laws are not designed to legally require payers to pay for unreliable biomarker tests if the payer can help it.

The Center for Genomic Interpretation is an independent and 501(c)(3) nonprofit organization that recommends that Health Insurance Payers do the following to minimize harm to plan members from inaccurate biomarker testing:

1) TEST ACCURACY. Create a smart network of laboratory tests that have either received FDA approval (see the list here https://lnkd.in/gXvcdXAV) or have received high scores in our nonprofit’s ELEVATEGENETICS BRILLIANT or ELEVATEGENETICS VERIFY assessments (learn more at https://lnkd.in/eGcd_sqV).

2) BILLING INTEGRITY. Use our nonprofit’s ELEVATEGENETICS LANDSCAPE service to detect systematic billing fraud from laboratories so that labs that lean heavily into billing fraud can be eliminated from payers’ smart networks.

3) PRIOR AUTHORIZATION OF COSTLY PRECISION THERAPIES. Use our nonprofit’s ELEVATEGENETICS CLARITY service as part of prior authorization for Precision Drug, Precision Medicine, Gene Therapy, or Surgical interventions that are being guided by Genetic or Genomic test results. This service readily identifies test reports that are likely false positives because the lab has not followed acceptable guidelines and standards.

Contact us at CGI to learn more. truth-in-genomics@genomicinterpretation.org or ph +1 (801) 810-4097.