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Elevate Your Expectations.

Identify Accurate Tests.

Avoid Over & Under Treatment.

Your Indispensable Partner in Evaluating Laboratory Test Quality

Elevate Your Expectations.

Identify Accurate Tests.

Avoid Over & Under Treatment.

Your Indispensable Partner in
Evaluating Laboratory Test Quality

ELEVATEGENETICS® is Maximizing Value in Precision Medicine By Promoting More Accurate Genetic & Genomic Testing, Analysis, & Reporting 

ELEVATEGENETICS® Service
The Problem
The Solution
Assesses if laboratory DNA sequencing tests can detect and rigorously classify clinically important genetic variants and therapeutic biomarkers.
The classification of variant(s) identified on the patient’s genetic or genomic test report is fact checked by experts as part of prior authorization for downstream drug or surgical interventions.
Determines the billing accuracy of a genetic or genomic test administered by a laboratory based on the technical landscape of that test, detecting some types of fraud, waste, and abuse.

The  Problem 

Not all clinical laboratory tests are sufficiently accurate.

Genetic and genomic tests with seemingly impressive technical specifications and laboratory accreditations may not be as accurate as they appear. This is because regulation, standardization and transparency expectations for laboratory developed tests lags far behind what is needed for stakeholders to distinguish between clinically valid and invalid tests.

Inaccurate genetic and genomic test results can oftentimes lead to inappropriate downstream medical care that can:

  • Harm patients
  • Increase wasteful spending in the healthcare system 

While no diagnostic test is perfect, efforts must be made to protect patients from diagnostic tests with avoidable and harmful flaws that can be discovered through leading edge independent evaluation.

The  Solution 

Use ELEVATEGENETICS® services to find the most accurate genetic and genomic tests.

The independent and patient-focused nonprofit organization, Center for Genomic Interpretation (CGI) provides unique and cutting edge accuracy and quality assessment services to help stakeholders discover the most accurate and clinically valid genetic and genomic tests. No other organization provides such powerful services. By doing so, CGI’s ELEVATEGENETICS services assist in:

  • The promotion of better clinical outcomes for patients
  • Improvement of  financial outcomes for an already overburdened healthcare system

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. 

This groundbreaking in silico program can be utilized to evaluate both somatic and germline genetic and genomic tests, such as comprehensive genomic profiling tests and hereditary cancer tests, among many other NGS tests.
ELEVATEGENETICS BRILLIANT is the only NGS proficiency testing evaluation which incorporates an assessment of:

  • 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…” 

The Science and Art of Clinical Genetic Variant Classification and Its Impact on Test Accuracy. Annual Review of Genomics and Human Genetics. 2021 Aug 31;22:285-307.

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.”

 

Quote from the CLIA Committee Next Generation Sequencing (NGS) Workgroup. CLIAC CDC NGS Workgroup Report, April 2019

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.

At times, billing codes utilized by laboratories are misaligned with the technical capability or scope of the tests. For example, a common misalignment is when a CLIA/CAP accredited laboratory bills the payer for the sequencing of expressed regions of genes, yet the laboratory’s application of technology consistently fails to adequately sequence all of the expressed regions. 

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)