NGS Controls & Reference Materials
Somatic Cancer
SHOP PRODUCTSSeraCare’s Seraseq® somatic cancer products realize the promise of precision oncology to analyze actionable and challenging genomic variants in patient samples. These patient-like reference materials enable the development, validation, and implementation of next-generation sequencing (NGS) assays for cancer diagnosis, treatment monitoring, and patient stratification.
Features and benefits
- Reference materials accurately mimic real patient samples
- Reduce troubleshooting time
- Improve consistency of assay performance
- Increase confidence in results
- Available in multiple formats (purified nucleic acid [DNA, RNA, or circulating tumor DNA (ctDNA)], plasma encapsulated ctDNA, or FFPE
- Include all variant types: SNVs, INDELs, CNVs, SVs and RNA fusions, and complex genomic signatures
- Manufactured in GMP-compliant and ISO 13485-certified facilities
Clinically relevant reference materials offer solutions for many oncology applications:
- Profiling of solid tumors and heme disorders
- Immuno-oncology
- Liquid biopsy
Tumor Profiling
Clinical implementation of NGS-based tumor profiling assays is often hampered by the lack of reference samples with the requisite breadth of clinically relevant genomic alterations and resemblance to patient samples. Seraseq® tumor profiling reference materials are highly multiplexed and patient-like, combining well-characterized normal or tumor cell lines with engineered biosynthetic variants, and address the needs of targeted DNA and RNA sequencing assays built to accelerate the application of NGS to clinical diagnosis and management of various cancers.
- Solid tumor DNA reference materials include multiple variants and variant types: Single nucleotide variants (SNVs), insertions, deletions, indels, copy number variations (CNVs) and large genomic rearrangements (LGRs). SeraCare has also developed unique reference materials for evaluating genomic instability resulting from homologous recombination deficiency (HRD).
- Fusion RNA reference materials are available to meet different needs, including pan-cancer profiling, solid tumor screening, targeted RNA panels, whole transcriptome RNA-seq, and cancer type- and gene-specific applications.
- Myeloid DNA and RNA reference materials incorporate important myelogenous leukemia DNA variants and RNA fusions, respectively, for analysis by hematology-focused targeted NGS assays.
- Unique lymphoma reference materials incorporate clinically relevant variants and translocations for analysis of lymphoid cancers.
SeraCare partnered with industry experts to develop a portfolio of immuno-oncology reference materials. Tumor mutational burden (TMB) and microsatellite instability (MSI) reference materials support the harmonization and validation of NGS assays for identifying patients most likely to respond to immunotherapy regimens. The Seraseq® portfolio includes the industry’s first tissue TMB (tTMB) and blood TMB (bTMB) reference materials, in addition to tumor-only and tumor-normal matched MSI reference materials.
Seraseq® ctDNA reference materials for liquid biopsy support and accelerate the clinical application of liquid biopsy-based NGS assays. Although very important for diagnosis of cancer, tissue biopsy is invasive, risky, and expensive. The use of blood-based samples to interrogate cancer, i.e., liquid biopsy, has gained importance both as a complementary tool as well as a surrogate sample type for tissue biopsies. The wide range of Seraseq® ctDNA reference materials, available in different formats allow the assessment of sensitivity and specificity required for profiling tumors in plasma samples and monitoring the presence of tumor-specific variants in ctDNA of patients undergoing therapy.
