Seraseq® Solid Tumor FFPE DNA Reference Material

Tissue biopsy samples that are formalin-fixed and paraffin-embedded (FFPE) are widely used in comprehensive genomic profiling (CGP) for cancer diagnosis. However, due to the chemical modifications introduced during the fixation process, FFPE samples present unique challenges that can compromise sequencing results starting from pre-analytical extraction steps through to downstream analysis. To ensure the accurate identification of clinically actionable variants, high-quality reference materials are essential for guiding and validating data quality and accuracy throughout the sample-to-result assay process.

Seraseq Solid Tumor FFPE DNA reference materials are expertly designed to mimic patient-like characteristics, enabling clinical labs and assay developers to confidently develop, validate, and routinely assess their solid tumor molecular assays. This unique product contains 74 biosynthetic DNA variants including SNVs, insertions, deletions, and translocations all within a single reference sample. By providing a realistic and reliable benchmark, this positive FFPE reference material enhances the accuracy of CGP assays and patient sample testing, supporting improved clinical decision-making in cancer care.

FEATURES AND BENEFITS

• Highly multiplexed containing 74 variants in 62 genes associated with solid tumors in a single sample.
• Includes SNVs (37), INDELs (4), deletions (18), insertions (5) and translocations (10)
• 65 variants are FDA drug targets
• For use in sample-to-result NGS workflows to analyze for mutation-positive variants in patient samples
• Manufactured in GMP-compliant and ISO 13485 certified facility
• Mutation targets measured by targeted NGS panel with select key variants further validated by dPCR

Specifications

Documents

• Product Sheet for Seraseq Solid Tumor FFPE DNA Reference Material (Product Sheet)
• Package Insert for Seraseq Solid Tumor FFPE Reference Material (Package Insert)
• Technical Spreadsheet for Seraseq Solid Tumor FFPE DNA Reference Material (Technical Spreadsheet)
• Seraseq FFPE Safety Data Sheet (Safety Data Sheet)

Ordering Information