Scantox offers advanced error-corrected sequencing to detect ultra-rare mutations and characterize mutational signatures. DuplexSeq™ provides mutation frequency, spectra, and mechanistic insight to support informed safety decisions.
Service information
DuplexSeq™ uses duplex sequencing to track both strands of DNA independently, eliminating sequencing errors that conventional approaches cannot distinguish from true mutations. This enables detection of ultra-rare mutations with error rates of less than 1 in 10 million bases.
The technology provides mutation frequency, mutation spectra, and trinucleotide signatures that can be compared to known carcinogenic patterns (e.g., COSMIC database) to support mechanism-of-action interpretation. Works across wild-type animals and any tissue source with high-quality DNA.
Go Beyond Mutation Frequency with DuplexSeq™
Flexible to fit your workflow
Reagent kits for your lab or full CRO service, from early discovery through regulatory preparation. One assay platform that integrates into existing toxicology programs.
Add a genomic safety endpoint
Error-corrected sequencing applied across any tissue source with high-quality DNA. Use wild-type animals and standard tissue types, including archived samples from existing studies.
From sample to insight
Cloud bioinformatics workflow with automated reports. You send samples, we deliver data ready for regulatory submission.
Beyond mutation frequency
Mutation spectra and signatures add mechanistic context to strengthen risk assessment and inform regulatory strategy.
Watch the Replay of our Recent Webinar to Learn More About DuplexSeq™ Mutagenesis Assays
Where DuplexSeq™ Fits Into Your Safety Assessment Strategy
Scantox provides comprehensive genetic toxicology services from early screening through OECD guideline GLP studies. DuplexSeq™ mutagenesis assays add molecular endpoints that strengthen weight-of-evidence assessments when mechanism, tissue relevance, or dose-response clarity is needed.
1. Ames-Positive Follow-Up Planning
A positive Ames result during development can be a project show-stopper. To navigate this significant mutagenicity concern, you need a structured approach to assess relevance and provide robust follow-up testing before first-in-human trials. DuplexSeq™ mutagenesis assays, in addition to Big Blue® Transgenic Rodent Gene Mutation Assays, enable mutation characterization and tissue-specific data as part of your overall follow-up strategy.
2. Nitrosamine and NDSRI Impurity Risk Assessment
Nitrosamine impurity evaluation frequently requires in vivo mutation frequency data suitable for benchmark dose (BMD) modeling, with the high sensitivity of the DuplexSeq™ technology ideal for supporting robust Acceptable Intake (AI) limits to be derived alongside the regulatory OECD 488 Big Blue® studies. DuplexSeq™ mutagenesis assays generate in vivo mutation frequency data from standard toxicology study tissues, with added value from mutation spectrum and mechanistic insight.
Note: The Enhanced Ames Test (EAT) is the recommended initial testing approach for N-nitrosamines. DuplexSeq™ in conjunction with our Big Blue® TGR capability, complements an overall testing and risk assessment strategy.
3. Augment In Vivo Programs with Genomic Safety
Add DuplexSeq™ mutation endpoints to existing in vivo programs using banked tissues (fresh/frozen DNA sources). Get an early view into genomic safety outcomes well in advance of later chronic safety studies, providing insights beyond genotoxicity outcomes
Quality, Reproducibility, and Confidence
DuplexSeq™ uses duplex sequencing—a technology originated by TwinStrand Biosciences—to eliminate background errors by tracking both DNA strands independently. This error-correction approach reduces error rates from approximately 0.1–1% (conventional NGS) to less than 1 in 10 million, enabling sensitive mutation detection not feasible with standard sequencing. Interlaboratory reproducibility has been demonstrated with near-perfect mutation frequency correlation (R ≈ 0.99) between processing sites.
Related Services
Build a cohesive genetic toxicology strategy by pairing DuplexSeq™ mutagenesis assays with:GLP OECD 471 Ames Test
OECD 488: Big Blue® Transgenic Rodent Gene Mutation Assay
In vivo gene mutation endpoint—ideal for bridging and regulator expectations.
GLP OECD 474 In Vivo Micronucleus Test
Detects chromosome damage in vivo—useful for follow-up, weight-of-evidence, and regulatory alignment.
Frequently Asked Questions
No. DuplexSeq™ is best positioned as a complementary approach that adds quantitative mutation measurement and mechanistic interpretability to a broader genetic toxicology strategy.
Yes. DuplexSeq™ mutagenesis assays work with wild-type rodent tissues and standard tissue types, including tissues repurposed from general toxicology studies.
The assays detect SNVs (single nucleotide variants), MNVs (multi-nucleotide variants), and short insertions/deletions, with mutation frequency reported per sample.
Not typically—analysis and report generation will be handled through an automated pipeline hosted at Scantox.
Yes—DuplexSeq™ mutation frequency and signature outputs support interpretation for nitrosamine impurity studies and help contextualize mutagenic outcomes within an overall risk assessment program.
Kits: Reagents shipped to your lab with protocol support for in-house execution. CRO service: Scantox conducts the complete study from sample receipt to final report, including tissue collection if needed.
