Analytical Validity, Clinical Validity, and Clinical Utility: What’s the Difference?

Posted by The Evidence Blog on February 7, 2017

clinical utility_1200.jpgGenetic testing is seemingly everywhere today. No longer are discussions of tumor profiling, gene panels, genomics and proteomics confined to the scientific realm. Major news outlets cover new advances in genetic testing, as well as some of the hidden risks associated with their exponential growth in the consumer market (See our blog Evidence Shines a Light on the Hidden Dangers of Genetic Testing). Technical innovations, such as next-generation sequencing, have accelerated the development of such tests. Consequently, there is increasing demand on you as both physicians and payers to provide your patients and clients with the best possible test solutions. But how do you decide? There are three essential criteria to consider when making your determinations regarding genetic testing.

“There is increasing demand on you as both physicians and payers to provide your patients and clients with the best possible test solutions. But how do you decide?”

Analytical Validity

Analytical validity is the test’s ability to accurately detect and measure the biomarker of interest (i.e., protein, DNA, RNA). Are the test results repeatable when performed under identical conditions? Are the test results reproducible when the test is performed in different conditions? Is the test sensitive enough to detect biomarker levels as they occur in a real-life setting?

Clinical Validity

Clinical validity asks the question: is the biomarker being tested associated with a disease or outcome or the response to a treatment? What is the clinical performance of the test, including its sensitivity (ability to identify those with the disease), specificity (ability to identify those without the disease), positive predictive value, and negative predictive value?

Schedule a demo of the Genetic Test Evaluation (GTE) Program.

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Clinical Utility

apples to apples_1200.jpgClinical utility is perhaps one of your most important considerations when determining whether or not to order or cover a genetic test. While the meaning of the term has some variability depending on the context or source, there is a largely agreed-upon definition. Four factors are generally considered when evaluating the clinical utility of a genetic test:

  • Patient outcomes – do the results of the test improve health outcomes (e.g., reduce mortality or morbidity) or other outcomes that are important to patients such as quality of life?
  • Diagnostic thinking – does the test confirm or change a diagnosis? Does it determine the genetic etiology for a condition or does it clarify the prognosis?
  • Decision-making guidance – will the test results determine the appropriate dietary, physiological, medical (including pharmaceutical), and/or surgical intervention?
  • Familial and societal impacts – does the test identify at-risk family members, high-risk race/ethnicities, and the impact on health systems and/or populations?

 “We’ll guide you through the ‘diagnostic odyssey’ of genetic testing.”

overwhelmed_1200.jpgThese three components encompass a dizzying amount of information for you as providers or payers to consider. Multiply that by the more than 65,000 (and growing) available genetic tests, and you’re presented with an overwhelming task in attempting to make an informed decision for your patients and clients.

But there is a solution.

The Hayes Genetic Test Evaluation (GTE) Program does the “deep dive” on genetic tests, giving you the time to be both more productive and to focus on best patient outcomes. We offer four separate types of reports:

  • GTE Indication: Assesses if genetic testing for an indication has clinical utility, including patient outcomes.
  • GTE Report: An evidence-based assessment of the clinical utility, clinical validity, and analytic validity of a specific test.
  • GTE Synopsis: A quick abstract review of the literature and a summary of pertinent test information, including cost and CPT codes.
  • GTE Comparison: Provides a side-by-side comparison of specific genetic tests.

We’ll guide you through the “diagnostic odyssey” of genetic testing. Schedule a demo today!

Schedule a Demo

Topics: Payers, Hospitals, Hayes Blog, Healthcare Evidence, Genetic Testing

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