Not all genetic tests are created equal. Seemingly equivalent genetic/genomic laboratories that have all the same accreditations and regulatory approvals vary wildly in the clinical accuracy of their tests. CGI’s ELEVATEGenetics™ makes key laboratory quality metrics available to decision makers. These quality metrics are of profound import to selecting safe and effective genetic and genomic tests, and have been previously unavailable to decision makers since they have gone unmeasured prior to CGI’s ELEVATEGenetics™ initiative.
While accurate and clinically valid genetic and genomic testing saves many thousands of lives and makes economic sense, inaccurate genetic and genomic testing costs lives or harms quality of life for over 100,000 patients in the US each year, and wastes over a billion dollars annually in the US healthcare system, as estimated by CGI. The patient harm and financial waste is due primarily to unnecessary or insufficient downstream medical intervention triggered by false positive or false negative results stemming from low quality genetic and genomic tests.
The commonly used benchmarks for quality assessment, including CLIA, CAP, ISO, New York state acceptance, ClinVar participation, and even FDA approval do not measure many of the scientific quality features of genetic or genomic tests that impact accuracy. ELEVATEGenetics™ is a service from the nonprofit Center for Genomic Interpretation aimed at filling this critical quality assessment gap so that more patients can gain access to more accurate genetic testing.
What is ELEVATEGenetics?
CGI’s ELEVATEGenetics service Engages Laboratories, Encourages Validity, and Appraises Test Efficacy (E.L.E.V.A.T.E.). Through this service, CGI conducts a survey and review (like an audit) of key quality features impacting the accuracy of the selected genetic/genomic test(s). The participation of the laboratory being assessed is required. Quality scores are then generated by CGI for that laboratory and test. These type of high impact quality scores have been previously unavailable for comparison between laboratories.
Labs can use their own CGI ELEVATEGenetics scores to identify areas for improvement.
Payers, contractors, and clinical groups can compare ELEVATEGenetics scores across seemingly equivalent genetic and genomic tests and labs to ensure that they are selecting and facilitating only high quality genetic tests for their members and patients to improve patient safety.
ELEVATEGenetics™ is a service from the nonprofit Center for Genomic Interpretation aimed at filling a critical information gap so that more patients can gain access to more accurate genetic testing.
What does ELEVATEGenetics measure?
The quality points in CGI’s ELEVATEGenetics laboratory and test review come in part from publications in the industry recommending quality improvements, and primarily from recommendation publications issued by CLIA, CAP, AMP, ACMG, CDC, ISO and ClinGen. Some of these organizations periodically publish quality standard recommendations that go unmeasured and unenforced. For example, CAP/AMP publishes recommended quality standards for genetic and genomic testing, yet CAP “enforced” accreditation standards are significantly lower in quality than its own recommended standards. CGI’s ELEVATEGenetics’ quality assessment service measures labs and their tests against selections from these higher recommended standards.
CGI’s ELEVATEGenetics does not replace CLIA, CAP, or FDA, but rather is complementary to them.
Who can commission an ELEVATEGenetics review?
CGI encourages individual laboratories to commission ELEVATEGenetics review(s) of their own lab processes to help laboratory directors identify areas for improvement. Laboratories pleased with their CGI ELEVATEGenetics review results are welcome to use their ELEVATEGenetics scores in marketing and contract negotiations.
Also, CGI’s ELEVATEGenetic service for assessing laboratories and their tests can be commissioned by health insurance payers, health system contractors, or clinician groups. These decision makers may also consider requiring CGI ELEVATEGenetics scores as part of contracting negotiations. Selecting higher quality genetic and genomic tests is not only better for patients, but also saves payers and health systems significantly by reducing the extraordinary higher costs of inappropriate downstream care triggered by inaccurate genetic or genomic test results.