IVD Assay Development

Seraseq® FFPE HRD Low-Positive RM

Material Number 0710-2645
Size 1 x 10 μm
Inventory Status In Stock
Unit EA
Genomic instability resulting from homologous recombination DNA repair deficiency (HRD) is a response biomarker to assess ovarian and breast cancer patient eligibility for PARP inhibitor and platinum-based therapies. HRD measurements have the potential to improve cancer therapy, however standardizing and democratizing HRD measurements remains challenging. LGC SeraCare has developed HRD reference materials to support the development, validation, and routine determination of HRD status in cancer patients.

•Derived from tumor and matched-normal human cell lines

•Blended to ~65% tumor content with SNP-matched normal cell lines

•Additional biosynthetic single-nucleotide variants (SNVs) of 4 homologous recombination repair (HRR) genes

•10 µm FFPE curl with DNA yield >100 ng per curl

•Full-process FFPE format reference material validated by NGS and microarray assays with various HRD algorithms (see the Data Sheet for more details)

•Manufactured in GMP-compliant, ISO 13485-certified facilities

Technical Spreadsheet for Seraseq FFPE HRD (High-Positive, Low-Positive, Negative) Reference Material

Doc type
Technical Spreadsheet

Seraseq FFPE HRD (High-Positive, Low-Positive, Negative) Reference Material Package Insert

Doc type
Package Insert

Seraseq FFPE HRD (High-Positive, Low-Positive, Negative) Reference Material Product Sheet

Doc type
Product Sheet

Seraseq FFPE Safety Data Sheet

Doc type
Safety Data Sheet

Seraseq FFPE HRD (High-Positive, Low-Positive, Negative) Reference Material

Doc type
Data Sheet

Seraseq FFPE HRD Low Positive Reference Material

Doc type
Certificate of Analysis/Technical Product Report
Lot #
10683435

Seraseq FFPE HRD Low Positive Reference Material

Doc type
Technical Product Report
Lot #
10641622

#Genomic Instability Score (GIS) calculated using Illumina TruSight™ Oncology (TSO) 500 HRD RUO assay which calculates a GIS using an algorithm licensed from Myriad Genetics. Illumina TSO 500 HRD is not available in Japan.

*From 1x10 µm FFPE curl using QIAGEN QIAamp FFPE DNA Tissue Kit/Qubit DNA HS quant

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