In 2015, SeraCare expanded their R&D facility and announced the formation of a new ''Precision Medicine' business unit focused on the development of technologies and products to enable the safe and effective expansion of precision medicine-driven diagnostics.

Since then, novel products for oncology, reproductive health, infectious disease and inherited disease have emerged from the SeraCare pipeline to support our clients’ development and validation efforts for precision medicine diagnostics. During this time, Seraseq technology was introduced to develop high-quality reference materials for next-generation sequencing applications.

SeraCare – New Tools for Clinical Genomics Assay

Next-generation sequencing (NGS) has revolutionized the field of genomics and how in vitro diagnostic (IVD) test developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. Before successfully launching a clinical assay, platform, or service, the tests must undergo rigorous development and thorough validation to ensure accuracy of the result.

SeraCare’s Seraseq™ comprehensive solution pairs highly consistent, quantitative, and highly multiplexed reference materials with easy-to-use software to greatly speed and simplify the capture and tracking of QC metrics.

Wide Range of Reference Materials

• Oncology
• Reproductive health
• Inherited disease
• Infectious disease

For Every Phase of Clinical NGS Assay

• Assay Development
• Assay Validation
• Laboratory QC

Clinically Relevant Formats

• Proprietary technology for the most patient-like reference materials
• FFPE cell lines to monitor and optimize your entire assay workflow
• Expedite development and validation with purified mutation DNA and RNA mixes.

 Actionable Variants

• Expert-designed constructs with a mix of common, rare, and challenging variants
• Range of variant types includes single nucleotide variants (SNVs), insertion-deletion mutations (INDELs), structural rearrangements (CNVs), and gene fusions
• Seraseq biosynthetic technology can precisely modulate allele frequency, gene copy numbers, and fusion events for accurate assessment of assay LOD.

Consistent Reference Material

• Highly multiplexed material with up to 40 variants in a single sample to maximize data output from each sequencing run
• Digital PCR ensures precise quantitation
• Manufactured in GMP-compliant and ISO 13485-certified facilities for consistency across time and material lots.