For Laboratories
Congratulations on taking the next step to ensure the patient results you deliver are accurate and actionable!
Whether you are choosing to be proactive or you are receiving encouragement from an insurance payer to prove your accuracy,
is here to help!
CLIA and CAP certification is not enough.
Can your lab:
- FIND the clinically actionable alteration AND
- CLASSIFY it accurately?
Your organization has options to identify and correct potential gaps that will assist you in analyzing quality.
Platinum Package
As shown above, the ELEVATEGENETICS® Platinum Package will assist your organization in ensuring that detection and classification of clinically important genetic variants and biomarkers is being done accurately (Brilliant), and billing is being handled properly (Landscape). CGI will also analyze the last 15 de-identified positive patient reports to ensure that the genetic variant classification(s) delivered were evidence based (Clarity).
Call (801) 810-4097 for pricing today!
Premier Package
As shown above, the ELEVATEGENETICS® Premier Package will assist your organization in ensuring that detection and classification of clinically important genetic variants and biomarkers is being done accurately (Brilliant), and billing is being handled properly (Landscape).
Call (801) 810-4097 for pricing today!
Classic Package
As shown above, the ELEVATEGENETICS® Classic Package will assist your organization in ensuring that detection and classification of clinically important genetic variants and biomarkers is being done accurately (Brilliant).
Call (801) 810-4097 for pricing today!
*For certain test types, Brilliant will be replaced with a test validation documentation report.
Most payers are unlikely to expect ElevateGenetics on every test offering from your test menu. We recommend starting with your highest volume tests.
The process for initial evaluation through reporting may take 3-4 months, depending on your lab’s internal processes. Also, many labs may be required to make changes that have resulted in decreased accuracy. Once these changes are made, a new evaluation through CGI may be completed.
ELEVATEGENETICS picks up where CLIA/CAP accreditation leaves off.
ELEVATEGENETICS helps you identify the most accurate tests.
“We believe this is a viable and credible way to ensure the labs’ quality and accuracy of testing.”
– Blue Shield of California, a CGI customer
BRILLIANT
ELEVATEGENETICS BRILLIANT™ is a performance evaluation on mock patients which scores Next Generation Sequencing (NGS) tests for their propensity to correctly identify and report actionable mutations and biomarkers. This will minimize false negative and false positive test results that may lead to inaccurate care decisions.
- Variant detection
- Variant naming
- Variant classification
- Lab-issued report clarity
For the first time since the advent of NGS, stakeholders can now compare* standardized performance metrics and can clearly and confidently identify strengths and weaknesses of different genetic and genomic tests through the use of ELEVATEGENETICS BRILLIANT.
*With permission from participating laboratories.
Sample Report – Single Test
Sample Report – Multi-Test Comparison*
“Upon reviewing validations, we’re refusing to reimburse 50% of these tests because we don’t think that the lab performance characteristics are good enough.”
–Payer from Tapestry Networks Diagnostic Quality Assurance Pilot, Summary of Themes, March 22, 2021.
CLARITY
ELEVATEGENETICS CLARITY™ supports prior authorization and care coordination when certain precision therapies are recommended based on a positive genetic or genomic test result.
ELEVATEGENETICS CLARITY can be used by payers or physicians to help determine whether a downstream medical intervention is likely to improve outcomes for a patient based on evidence supporting the variant classification.
The classification of variants identified on the patient’s genetic or genomic test report is fact checked by experts through a careful assessment of existing scientific findings, which helps provide a clearer picture of appropriate next steps.
Applications for ELEVATEGENETICS CLARITY can include assisting in prior authorizations for:
- Gene therapies
- Approval of oncology precision therapeutics
- Risk-reducing surgical interventions associated with inherited disorders
“The most significant contributor to false positive test results is imperfect variant classification…”
Sample Report
“A problem for the industry is that…[the same] variant is classified as a ‘variant of unknown significance’, ‘likely benign’, and ‘pathogenic’ by different laboratories due to variations in interpretation.”
LANDSCAPE
ELEVATEGENETICS LANDSCAPE™ evaluates the billing accuracy of a genetic or genomic test administered by a laboratory based on the technical specifications of that specific test and/or laboratory.
From a quality perspective, this represents a potential source of false negatives.
From a billing perspective, the laboratory is billing for tests it has failed to deliver in full.
ELEVATEGENETICS LANDSCAPE is more foundational than a billing code specificity analysis. In a specificity analysis, the payer will determine if the most specific billing code(s) were used by the laboratory for the test they describe.
In contrast, LANDSCAPE checks to make sure that the test the laboratory describes to the payer is even possible based upon the application of the laboratory’s technologies.
ELEVATEGENETICS LANDSCAPE can be used as a standalone quality check or as a precursor to a billing code specificity check. In addition, LANDSCAPE also pairs well with ELEVATEGENETICS BRILLIANT to evaluate sequencing tests’ validity and usefulness.
Sample Report for a Hereditary Cancer Test
Sample Report for a
Noninvasive Prenatal Test (NIPT)
