Test Classification Current Value

This test was developed and its performance characteristics validated by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

Test Classification Value Prior to 7/13/2023 10:05am

This test was developed and its performance characteristics validated by LabCorp. There is no FDA approved assay for this test. As a lab developed test (LDT), approval or clearance by the FDA is not required. This test may be used for clinical purposes and should not be regarded as investigational or for research.