VariantFlex Custom NGS Library

NGS Standards Customized For Your Needs

We design and produce sophisticated, highly multiplexed reference materials tailored to your specifications. With our custom services, you have a high degree of flexibility, access to our technical and scientific experts, and a rapid turnaround time for your unique requirements and complex biomarkers. 

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NGS Standards Customized For Your Needs

NGS Lab Pipette

As NGS panels grow to include an ever increasing number of important biomarkers, so too must the reference standards 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 custom NGS library, 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 as little as six weeks, thanks to our streamlined process and flexible biosynthetic technology.

  • Select from over 200 clinically relevant variants across 50 genes or specify a custom sequence 
  • Broad coverage of variant types including SNVs, INDELs, RNA gene fusions, SVs, and CNVs
  • Size profiles for solid tumor and cell-free DNA applications in a variety of matrices
  • 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 (such as T790M) as low as 1.25% to help stratify 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)
  • Tumor profiling routine QC: Custom version of off-the-shelf 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. Our VariantFlex platform offers a time-efficient, cost-effective solution to obtaining your mutations and gene fusions of interest in the best format for your assay.

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