Hayes GTE Rating
The Hayes GTE Rating, a rating system developed by Winifred S. Hayes, Inc., reflects the strength and direction of the evidence regarding the safety and efficacy of a genetic test, its impact on health outcomes, indications for use, patient selection criteria, and comparison with other technologies. The ratings are scaled A through D and are defined as follows:
|
A
|
Established benefit. A high level of positive published evidence regarding analytical validity, clinical validity, and clinical utility for the application(s) supports use of the test. |
|---|---|
|
B
|
Some proven benefit. A moderate level of positive published evidence regarding analytical validity, clinical validity, and clinical utility for the application(s) supports use of the test. Further research is required. |
|
C
|
Potential but unproven benefit. Some positive published evidence regarding analytical validity and/or clinical validity for the application(s) supports use of the test, but clinical utility has not been demonstrated because data are sparse and the level of evidence is low, or data are inconsistent or conflicting. |
|
D1
|
No proven benefit – health outcomes. The test has been shown to lack analytical validity, clinical validity, and/or clinical utility for the cited application(s). |
|
D2
|
No proven benefit – insufficient evidence. Evidence is insufficient to assess the analytical and/or clinical validity of the test for the cited application(s). |