To determine coverage, a Technical Assessment (TA) may be required for molecular assays that are laboratory developed tests (LDT), include Next Generation Sequencing (NGS) technology, employ new or novel technology, or have undefined or unproven clinical utility. 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 (firstname.lastname@example.org).