Certificate

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Highlights

Genetic testing for BRCA ½ mutations for detecting breast and ovarian cancer

BRCAaccuTest™ & BRCAaccuTest™PLUS is a regent for producing libraries for
analyzing the BRCA ½ genes using the NGS (next-generation sequencing) method,
which analyzes genomic DNA derived from blood or FFPE tissues.

Application

BRCAaccuTest™ and BRCAaccuTest™ PLUS are a reagent kit for producing libraries for analyzing the BRCA1 and BRCA2 genes using the next generation sequencing (NGS) method, which analyzes genomic DNA derived from blood or FFPE tissue.

  • For breast and ovarian cancer patients
  • For HBOC (Hereditary breast and ovarian cancer syndrome) patients
  • For family history or the age of breast cancer incidence
Specifications

BRCAaccuTest™ PLUS
Certification CE-IVD
Target disease Breast/Ovarian cancer
HBOC (Hereditary breast and ovarian cancer syndrome)
Target Enrichment method Amplicon based method
Quantity 12 (6+6) test
(1 test each for control DNA)
24 test
(1 test for control DNA)
Specimen Blood, FFPE tissue, Tissue biopsy
In-put DNA quantity 10-30 ng
Target gene BRCA1 / BRCA2
Target region 22.4 kb (all protein coding region, splicing regions, selected promoter, UTR, intron regions)
amplicon 160 (2 pools)
Hands on time >5 hrs
Variants type SNV, In, Del, Dup, CNV*
NGS platform & reagent kit illumina MiSeq, MiSeq Dx / MiSeq Reagent Nano, Micro kit, v2, 300cycles
Samples throughput Germline (11) / Somatic (5) Germline (23)
Analysis solution NGeneAnalySys™ (CE)

*CNV: RUO, Research Use Only

Other information

Supplier

NgeneBio

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