Total solution for genetic breast cancer BRCA genetic test(CE-IVD)
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.
- 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
|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|
|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|
BRCAaccuTest™ is provided for research use only (RUO).
Not for use in diagnostic procedures.
BRCAaccuTest™ is provided for research (RUO) and diagnostic (CE-IVD) purposes.