TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Basic Information
- Primary DI
- 06959094210564
- Basic UDI-DI Code
- B-06959094210564
- Reference
- 8.06.0047
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx® HRD Focus Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay intended for qualitative determination of homologous recombination deficiency (HRD) status via detection and classification of single nucleotide variants (SNVs) and insertions and deletions (InDels) in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes and the determination of the Genomic Scare Score (GSS) which is an algorithmic measurement of genomic instability status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The assay is intended to aid in identifying ovarian cancer patients with positive HRD status. This assay is not automated and is for laboratory professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
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