To determine compliance with a policy, a Technical Assessment (TA) may be required for molecular assays that are laboratory developed tests (LDT). Before submitting a TA, labs must register a test and obtain a unique identifier through the DEX™ Diagnostics Exchange.
In order to receive favorable review results, the assay must demonstrate clinical utility (CU) and meet analytical and clinical validity (AV/CV) standards.
In order to reduce delays and unfavorable determinations, please ensure that the TA submission is complete. Select the link below for specific instructions on how to submit all required documentation for a TA.
Technical Assessments should be sent to email@example.com.