GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-RepotrectinibCTAPA
- Basic UDI-DI Code
- B-RepotrectinibCTAPA
- Reference
- Repotrectinib CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Almac Diagnostic Services Limited Liability Company
Additional Description
The investigational use only Repotrectinib CTA is a qualitative in vitro diagnostic assay that uses targeted next generation sequencing to detect fusions in ALK, ROS1, and NTRK1-3 genes. The assay will profile RNA isolated from formalin fixed paraffin embedded (FFPE) solid tumor tissue collected from patients with locally advanced or metastatic solid tumors (including primary central nervous system (CNS) tumors) and will be used to determine molecular eligibility for enrollment onto the TRIDENT-1 Phase 2 clinical trial. This is for professional use only and is to be performed only at Almac Diagnostic Servicesโ Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP)-accredited laboratory located at 4238 Technology Drive Durham, North Carolina (NC) 27704 United States of America (USA).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).