BRCA Complete™

Product Name/Description
No. of Samples
Product Code
BRCA Complete™ (For Illumina® Platforms)
Up to 40
BRCA-NGS
BRCA Complete™ Expanded Panel (For Illumina® Platforms)
Up to 40
BRCAX-NGS

 

 

EntroGen BRCA Complete™: a complete next generation sequencing (NGS) solution for detecting clinically relevant BRCA1 and BRCA 2 mutations.

BRCA Complete™ Expanded Panel offers extended coverage of CHEK2, PALB2, RAD51C and TP53.

 

EntroGen BRCA Complete™ is a complete NGS solution from DNA to interpreting sequencing data that detects germline and somatic BRCA1/BRCA2 mutations with comprehensive coverage, specificity, and high sensitivity. The enhanced BRCA Complete™ Expanded Panel now covers more genes with CHEK2, PALB2, RAD51C and TP53 added to BRCA1/BRCA2.

BRCA Complete™ and BRCA Complete™ Expanded Panel are compatible with blood, fresh frozen, and formalin fixed paraffin embedded (FFPE) samples. Allele dropouts and off-target reads are reduced through a tiled amplicon PCR approach coupled with a high fidelity polymerase for target enrichment. Reagents for library preparation and clean-up are included, as well as a local, user-friendly software designed to reduce the bioinformatics burden on the end-user by calling clinically relevant mutations directly from VCF files. Sample and library quality control assays (DNA Fragmentation Quantification assay, Library Quantification Kit for Illumina®) are available to ensure high quality data without the need for repeat sequencing.

 

 

From DNA to results in approximately 24 hours with 4 hours of hands-on time including sample and library QC.

Both panels offer all reagents necessary for target enrichment and library construction for Illumina® platforms from DNA isolated from patient samples.  Sample quality assessment assays (DNA Fragmentation Quantification assay, Library Quantification Kit for Illumina®) are available to ensure samples and sequencing reagents are not wasted. The complimentary software queries two independent databases to call clinically relevant variants based on Illumina® output reports.

 

brca-workflow

 

 

EntroGen Variant Analysis (EVA)

Data Analysis Software

BRCA Complete™ and BRCA Complete™ Expanded Panel come with user-friendly, locally installed software to streamline reporting and simplify data interpretation.  VCF sequencing files are queried by two independent databases providing end-users with the latest, most clinically relevant biomedical information for each detected variant.  Our automated reporting software is designed to reduce the amount of time, cost and complexity associated with data analysis by minimizing the time spent interpreting data.  Comprehensive reports allow end-users to quickly determine variant calling, clinical relevance, treatment recommendations and current clinical trials.  Reports can also be easily exported and filtered for a more focused data review.

 

EVA for BRCAX

 

Equipment & Materials:

BRCA Complete™ and BRCA Complete™ Expanded Panel require the following equipment:

  • Illumina® MiniSeq. Illumina® MiSeq or NextSeq 500 are also compatible.
  • PCR thermocycler.
  • Real-time PCR machine (for sample and library QC assays).
  • Magnetic rack (for amplicon and library clean-up).

Both kits include reagents for:

  • Target enrichment.
  • Library preparation (indexes and adaptor oligos for Illumina® sequencing).
  • Amplicon and library clean-up (magnetic beads are included).

The reagents in the kits are to prepare sequencing libraries for up to 40 samples.

 

Intended Use:

USA: BRCA Complete™ and BRCA Complete™ Expanded Panel are provided for research use only (RUO). Not for use in diagnostic procedures.

Europe: BRCA Complete™ is provided for research use (RUO) and diagnostic (CE-IVD) purposes.  BRCA Complete™ Expanded Panel is provided for research use only (RUO).  Not for use in diagnostic procedures.

Overview BRCA Complete™

  • Detects all clinically relevant mutations in BRCA1 and BRCA 2 exomes from blood, fresh frozen, and high quality FFPE tissue samples.
  • Analytical sensitivity as low as 5% MAF.
  • Includes reagents for target enrichment; library preparation, clean up, sample and library QC.
  • Compatible with Illumina® NextSeq 500, MiniSeq, and MiSeq sequencers.
  • Complimentary data-analysis software for local installation available.

Overview BRCA Complete™ Expanded Panel

  • Detects all clinically relevant mutations in BRCA 1, BRCA 2, CHEK2, PALB2, RAD51C and TP53 exomes from blood, fresh frozen, and high quality FFPE tissue samples.
  • Analytical sensitivity as low as 5% MAF.
  • Includes reagents for target enrichment; library preparation, clean up, sample and library QC.
  • Compatible with Illumina® NextSeq 500, MiniSeq, and MiSeq sequencers.
  • Complimentary data-analysis software for local installation available.

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