Test Classification Current Value

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Test Classification Value Prior to 11/21/2022 10:01am

This test was developed and its performance characteristics have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test. This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.