Sandy, UT / EIN Newswire / March 21, 2023 – The independent and nonprofit Center for Genomic Interpretation’s (CGI) is launching ELEVATEGENETICS VERIFY™, which is part of the ELEVATEGENETICS® suite of services. The new CGI VERIFY Program helps analyze laboratory internal validation documentations to assess whether or not the clinical and analytical claims of the applicable genetic and genomic tests are substantiated by the laboratory’s own validation data.
Recently, a physician and senior medical director with a large national insurer stated that CGI’s services are considered to be the gold standard, and that laboratories need to be accountable not just for their processes, which is what CLIA and CAP do, but also the reported outcome.
The ELEVATEGENETICS Programs are gaining momentum as innovative assessment tools for health insurers and purchasers, clinicians, drug developers, regulators, and others to determine which clinical genetic and genomic tests are the most accurate and valid.
“Genetic and genomic tests range from straightforward to extremely complex,” adds Dr. Julie Eggington, MS PhD, CGI CEO and Co-Founder. “Payers are having a hard time determining the validity of novel complex testing related to precision medicine. Typically these novel tests are marketed as polygenic risk score (PRS) tests, genomic signature, or artificial intelligence (AI) driven tests. Many labs are making claims about their tests that their own validations may not have demonstrated. We’ve developed ELEVATEGENETICS VERIFY™ to round out our assessment services to catch these potentially dubious claims.”
ELEVATEGENETICS VERIFY evaluates a genetic or genomic test’s validation documentation against its clinical and technical claims to give three distinct ratings: 1) Claims are substantiated, 2) claims are partially substantiated, or 3) claims are unsubstantiated. The methods and findings unique to each review are outlined in the final ELEVATEGENETICS VERIFY report. To see a sample of the ELEVATEGENETICS VERIFY report, click here.
“It’s such a simple idea really,” says Garry Carneal, Schooner Strategies President and CEO and leading accreditation expert. “CGI uses their experienced biostatisticians to check to see if the lab is actually walking the walk by having to demonstrate that its new or existing test does what the lab claims it does.” Carneal notes further “In working closely and advising the Center for Genomic Interpretation, I’ve been surprised at how often genetic or genomic test findings can result in false positives or false negatives which can hurt the patient. Often, these errors are based on the failure of the lab to properly analyze, document and classify evidenced-based pathways and potential variants. Now, interested parties such as payers or patients can just ask the lab to show them CGI’s independent ELEVATEGENETICS VERIFY results, to verify if the lab’s claims have stood up to third party review. It’s such a simple solution.”
CGI’s new ELEVATEGENETICS VERIFY service is the fourth addition to the other three ELEVATEGENETICS services: BRILLIANT, CLARITY, and LANDSCAPE. 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, and the integrity of billing codes. Thus laboratories that are in negotiations with payers have the ability to show an unbiased evaluation verifying their tests can do what they state they can do, which is not the norm in the current Laboratory Developed Testing (LDT) space.
For more information about CGI, see www.genomicinterpretation.org.
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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 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, payors, pharmaceutical developers, policy makers and laboratories.