IVD Assay Development

Seraseq® ctDNA Lymphoma Mix AF1%

Material Number 0710-3182
Size 1 x 25 uL
Inventory Status In Stock
Unit EA

To help clinical labs performing NGS-based lymphoid testing better develop, characterize, validate and routinely assess lymphoid diseases by NGS assays, SeraCare has developed the Seraseq® Lymphoma DNA Mutation Mix, Seraseq FFPE Lymphoma Reference Material and SeraSeq ctDNA Lymphoma DNA Mutation Mix,, the first set of comprehensive lymphoid cancer NGS assay reference materials. These unique products include clinically important SNVs, INDELs and gene fusions important in lymphoma disease diagnosis and prognosis. Variants are present against a single well-characterized genomic background (GM24385) at clinically relevant allele frequencies, precisely quantitated by digital PCR assays.

FEATURES AND BENEFITS

  • Develop and validate Lymphoid-based NGS assays with confidence using a highly multiplexed reference material containing biomarkers important in Lymphoma cancers.
  • Provide robust sensitivity to detect clinically-relevant mutations at variant allele frequencies that establish and validate assay LoD claims.
  • Mutation targets are quantitated using highly sensitive digital PCR as well as a custom NGS assay.
  • All mutations are blended against GM24385 human genomic DNA as background ‘wild-type’ material.
  • Available as purified gDNA, ctDNA, and FFPE curls for end-to-end assay performance monitoring
  • Manufactured in GMP-compliant and ISO 13485-certified facilities.
  • Seraseq ctDNA Mutation Mix Non-Requirement Letter

    Doc type
    Safety Data Sheet (Non-Requirement Letter)

    Seraseq® Lymphoma DNA Products

    Doc type
    Product Sheet

    Seraseq® ctDNA Lymphoma Mix, AF1%, AF0.5%, AF0.1%

    Doc type
    Package Insert

    Seraseq ctDNA Lymphoma Mix AF1%

    Doc type
    Technical Product Report
    Lot #
    10688078