VariantFlex Custom Platform

Next-generation sequencing (NGS) has revolutionized the genomics field and how IVD developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease and genetic conditions.  With NGS-based assays displacing older methodologies worldwide, it is extremely important that they are proven to be robust, accurate, consistent, and cost-effective in delivering timely results to improve patient care.

As NGS panels grow to include an ever increasing number of important biomarkers, so too must the reference materials used for development, validation, and routine QC. But sourcing sufficient quantities of remnant patient specimens or cell lines bearing all of the necessary variants is expensive, time consuming, and can leave you short of rare or challenging mutations.

With SeraCare’s VariantFlex platform, you can easily get the variants you need at your desired allele frequencies in the format that fits your assay. Your custom reference material will arrive in weeks, thanks to our streamlined process and flexible biosynthetic technology.

Easily build custom reference materials

  • Easily select variants from a library or made to order, and configure to your specific assay
  • Over 180 clinically relevant variants across 45 genes in our constantly growing library
  • Range of variant types – SNVs, Indels, RNA gene fusions, CNVs, Trisomies
  • Patient-like profile, complexity, and sequencing performance attributes
  • Scale easily from development to validation and post-launch run monitoring
  • Targets precisely quantitated with digital PCR
  • Manufactured in GMP-compliant and ISO 13485-certified facilities

Featured Projects

  • NIPT assay development – Customized trisomy 21, 18, 13, and euploid materials across a range of fetal fractions to support a ground-breaking new platform and consumable launch
  • Cancer assay development – Custom cancer panel with over 60 variants at 10% allele frequency to support a platform and system for targeted cancer applications
  • Liquid Biopsy validation – Custom ctDNA panel with key therapeutic variants as low as  1.25% to help identify patients for targeted drug therapy
  • HIV-1 assay validation – Custom HIV-1 and HCV-positive run controls covering specific variants at 5,000 copies per sample and specific mutation frequency (recombinant virus design)
  • Tumor profiling routine QC – Custom version of existing SeraseqTM tumor DNA reference materials to monitor daily run performance of a tumor profiling assay

Partner with SeraCare 

With over 30 years providing quality control reagents to IVD developers and clinical laboratories worldwide, we help solve assay development challenges. Seraseq VariantFlex offers a time-efficient, cost-effective solution to obtaining your mutations and gene fusions of interest.

Contact Us to Get Started