GENETIC TESTS - OTHER
Basic Information
- Primary DI
- D-SIRPAqPCRAU
- Basic UDI-DI Code
- B-SIRPAqPCRAU
- Reference
- SIRPA qPCR 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 Signal Regulatory Protein Alpha (SIRPA) real-time polymerase chain reaction (qPCR) CTA is a qualitative qPCR in vitro diagnostic assay that detects the polymorphism rs386811663 (alleles GT>AC) within exon 3 of the SIRPA gene relative to transcripts NM00104002 (V1 SIRPA sequence) and BC075849.1 (V2 SIRPA sequence) and allows for allelic discrimination of V1/V1, V1/V2 and V2/V2 genotypes in genomic deoxyribonucleic acid (DNA) isolated from whole blood samples collected in ethylenediaminetetraacetic acid (EDTA) in Paxgene DNA CE-IVD tubes. The assay is used with the QuantStudio™ Dx instrument. The assay is intended to be used to identify subjects with advanced solid malignancies who are molecularly eligible for enrolment onto studies evaluating BI 765063. The SIRPA qPCR CTA is intended for laboratory professional use only. To be performed only at Almac Diagnostic Services’ Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, UK and 4238 Technology Drive, Durham, NC, 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).