Genetic Testing

Tables

Tier 1
Tier 2
Tier 3

Genomic Tests and Family History by Levels of Evidence

The CDC Office of Public Health Genomics ranks the following list for levels of evidence of genomic tests and family health history in practice . This approach was based on a paper by Khoury

and updated in accordance with criteria presented by a 2014 paper in Clinical Pharmacology and Therapeutics . The criteria are shown in the following figure to provide additional information to our readers. This list is updated on an ongoing basis andprovided only for informational purposes to researchers, healthcare providers, public health programs and others.

Green

FDA label requires use of test to inform choice or dose of a drug
CMS covers testing
Clinical practice guidelines based on systematic review supports testing

Yellow

FDA label mentions biomarkers*
CMS coverage with evidence development
Clinical practice guideline, not based on systematic review, supports use of test
Clinical practice guideline finds insufficient evidence but does not discourage use of test
Systematic review, without clinical practice guideline, supports use of test
Systematic review finds insufficient evidence but does not discourage use of test
Clinical practice guideline recommends dosage adjustment, but does not address testing

Red

FDA label cautions against use
CMS decision against coverage
Clinical practice guideline recommends against use of test
Clinical practice guideline finds insufficient evidence and discourages use of test
Systematic review recommends against use
Systematic review finds insufficient evidence and discourages use
Evidence available only from published studies without systematic reviews, clinical practice guidelines, FDA label or CMS labels coverage decision

*Can be reassigned to Green of Red of one or more conditions in these categories apply