GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-MPSCTAPC
- Basic UDI-DI Code
- B-MPSCTAPC
- Reference
- MPS CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Almac Diagnostic Services Limited
Additional Description
The Molecular predictive signature clinical trial assay (MPS CTA) is a qualitative in vitro investigational assay which uses gene expression profiling of RNA derived from fresh ulcerative colitis (UC) tissue samples collected in RNALater using the ThermoFisher QuantStudio Dx platform. The assay is intended to be used for molecular eligibility screening and/or stratification of patients within clinical trials evaluating the safety and effectiveness of therapeutic(s) being developed by JRD for treatment of ulcerative colitis patients. The MPS CTA is intended for investigational and laboratory professional use only, to be performed only at Almac Diagnostics Services Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP) accredited laboratory located at 19 Seagoe Industrial Estate, Craigavon, UK.
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).