GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-RARACTA7R
- Basic UDI-DI Code
- B-RARACTA7R
- Reference
- RARA CTA
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Almac Diagnostic Services Limited Liability Company
Additional Description
The RARA Clinical Trial Assay (CTA) is a qualitative reverse transcription polymerase chain reaction (RT-qPCR) based in vitro diagnostic device that measures messenger ribonucleic acid (mRNA) expression levels of retinoic acid receptor alpha (RARA) in CD34+ and/or CD117+ cells within the mononuclear cell population derived from blood. The assay will be used to screen subjects with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) to identify those that are molecularly eligible for enrolment onto clinical studies evaluating SY-1425 (tamibarotene), based on RARA biomarker status. The RARA CTA is intended for laboratory professional use only, and 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, NC, USA, 27704.
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).