Breast Cancer Kit

BRCAaccuTestTM

Total solution for genetic breast cancer BRCA genetic test(CE-IVD)

brcaaccutest_01
Introduction

Clinically validated next generation sequencing (NGS) panel and data analysis software for rapid and reliable detection of BRCA 1/2 mutations

BRCAaccuTestTM is a next generation sequencing (NGS)-based in vitro diagnostic (IVD) product which detects mutations in BRCA1 /BRCA2 genes. BRCAaccuTestTM consists of NGS panel for detecting variants and clinical data analysis software (S/W). Rapid and precise detection of various mutations in BRCA 1/2 with NGS can be accomplished and the user-oriented analysis software enables convenient generation of clinical report.

Features
  • Detection of mutations in the whole exon region coding for BRCA1 and BRCA2 gene proteins
  • Experiment and decryption completed in 2 days
  • Using DNA extracted from blood
  • PCR amplicon-based library production
  • Provide data QC, analysis and automated variant information by using optimized analysis software for BRCA1 and 2 panels
  • Production and management from GMP and ISO 13485 certified organizations
  • IVD(CE) / RUO
Procedure
BRCAaccuTest04@2x-1-736x195
BRCA1 & 2 DNA Library Preparation
BRCAaccuTest05@2x
Specification
Category Contents
Target Design Target Region BRCA1 & BRCA2 protein coding exon region (about 17kb)
Amplicon Size 152 ~ 284 bp (average 230 bp)
Primer Pools 131 primer pairs
Sequencing Input DNA 10 ~ 50 ng
Samples 23 samples + 1 control DNA
Sequencer MiSeqDx, MiSeq
Reagent Kit MiSeq Reagent Nano Kit v2 300 cycles
Read Cycles 2 x 150 bp (paired-end reads)
Turn Around Time Total in 2 days : library prep (1 day) + sequencing run (1 day)
Sequencing Data Amplicon Coverage . Average coverage ≥ 200X . Minimum coverage ≥ 20X
Uniformity Amplicon over average coverage * 0.2 ≥ 98%
Variants Differentiate 100% of SNV, INDEL Heterozygous & homozygous mutations 
Analysis Solution NGeneAnalySys™ analysis software
Analyzing Time 1hr / sample
Information
Cat.No Contents Reactions Price

NGB111U

BRCAaccuTestTM

  • BRCA Amplicon Primer Mix 1
  • BRCA Amplicon Primer Mix 2
  • Hot Start PCR I Master Mix
  • Ligation Mix
  • Amplicon DNA Adapter
  • PCR II Barcoded Primer Mix N1~N24
  • PCR II Master Mix
  • Nuclease-Free Water
  • Control DNA, 5 ng/ul
  • Resuspension Buffer
  • Cleanup Beads
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[Intended Use]

BRCAaccuTest™ is provided for research use only (RUO).

Not for use in diagnostic procedures.

Europe

BRCAaccuTest™ is provided for research (RUO) and diagnostic (CE-IVD) purposes.