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TEST:
AmoyDx® HANDLE HRR NGS Panel

Type:
CE Marked
Related tests:

Details

Evidence
The AmoyDx® HANDLE HRR NGS Panel (Reversible Terminator Sequencing) is intended for qualitative detection of single nucleotide variants (SNVs) and insertions and deletions (Indels) variants in protein coding regions and intron/exon boundaries of 27 HRR genes (AR, ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CHEK1, CHEK2, ESR1, FANCA, FANCL, HDAC2, HOXB13, MRE11, NBN, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, STK11 and TP53), and SNVs/Indels variants in hotspot regions of 5 driver genes (BRAF, ERBB2, KRAS, NRAS and PIK3CA) using DNA isolated from peripheral whole blood samples, fresh-frozen tumor tissue or formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. In addition, the kit also allows the detection of large rearrangements (LRs) of the BRCA1 and BRCA2 genes from blood-derived DNA. The kit is intended to be used by trained professionals in a laboratory environment.
Gene:
AR (Androgen receptor), ATM (ATM serine/threonine kinase), ATR (Ataxia telangiectasia and Rad3-related protein), BARD1 (BRCA1 Associated RING Domain 1), BRAF (B-raf proto-oncogene), BRCA1 (Breast cancer 1, early onset)
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Method:
Next-Generation Sequencing (NGS)