About
TwinStrand Biosciences has developed Duplex Sequencing® (DuplexSeq™), a breakthrough NGS platform that reduces sequencing error rates from approximately 1-in-100 down to 1-in-10 million. By independently capturing and comparing both complementary strands of each individual DNA molecule, the technology eliminates the background noise that masks rare, biologically meaningful variants in standard sequencing workflows. The platform powers two flagship assays: the AML Assay, which identifies acute myeloid leukemia–related mutations with 100-fold higher resolution than conventional methods — enabling measurable residual disease (MRD) monitoring — and the DuplexSeq™ Mutagenesis Assay, which quantifies mutation frequency, spectra, and signatures directly from DNA for genotoxicity and mutagenicity studies. TwinStrand also offers services for Nitrosamine Testing and contract Mutagenesis Testing, catering to pharmaceutical companies navigating regulatory requirements. The technology has been validated in inter-laboratory studies and is undergoing OECD regulatory approval processes, signaling strong acceptance in the regulatory science community. Researchers can start with off-the-shelf kits or collaborate with TwinStrand on custom assay development. The cloud-based informatics backend handles data analysis seamlessly. The platform is intended for research use only and serves oncology researchers, toxicologists, pharmaceutical scientists, and regulatory affairs professionals who require accuracy well beyond what standard NGS can deliver.
Key Features
- Duplex Sequencing® Error Correction: Independently sequences both strands of each DNA molecule and compares results to reduce error rates from 1-in-100 to 1-in-10 million, revealing variants hidden from standard NGS.
- AML Assay with 100× Higher Resolution: Detects AML-related mutations with dramatically higher sensitivity than conventional methods, enabling measurable residual disease (MRD) monitoring in hematological malignancies.
- Mutagenesis Assay & Genotoxicity Testing: Quantifies mutation frequency, spectra, and signatures directly from DNA for regulatory mutagenicity and carcinogenicity assessments, with inter-laboratory validated results.
- Cloud-Based Informatics Pipeline: Proprietary cloud bioinformatics processes and analyzes Duplex Sequencing data, removing the burden of in-house infrastructure and enabling scalable, reproducible results.
- Flexible Off-the-Shelf & Custom Kits: Researchers can deploy ready-made assay kits immediately or collaborate with TwinStrand scientists to develop custom kits tailored to specific research needs.
Use Cases
- Monitoring measurable residual disease (MRD) in acute myeloid leukemia patients to assess treatment efficacy and detect early relapse.
- Conducting regulatory mutagenicity and genotoxicity testing for pharmaceutical compounds in compliance with OECD and ICH guidelines.
- Testing pharmaceutical products and APIs for nitrosamine contamination in response to FDA and EMA regulatory requirements.
- Studying mutation signatures and spectra from environmental mutagens or carcinogens in research and regulatory toxicology settings.
- Tracking low-frequency somatic mutations in cellular immunotherapy products to assess genomic stability and safety profiles.
Pros
- Unmatched Sequencing Accuracy: Error rates of 1-in-10 million far exceed standard NGS accuracy, making it possible to detect biologically significant rare variants that other platforms miss entirely.
- Regulatory Validation & OECD Recognition: The Mutagenesis Assay has undergone inter-laboratory validation and TwinStrand is pursuing OECD regulatory approval, giving results credibility in regulatory submissions.
- Versatile Application Scope: Supports diverse research needs from oncology MRD monitoring to pharmaceutical nitrosamine testing and cellular immunotherapy tracking under a single platform.
- Cloud-Powered Scalability: The cloud-based informatics backend removes the need for on-premise compute infrastructure, enabling labs of any size to access high-throughput analysis.
Cons
- Research Use Only: Duplex Sequencing products are explicitly not for diagnostic procedures, limiting direct clinical deployment without additional regulatory clearance.
- Enterprise Pricing with No Self-Serve Tier: As a specialized B2B platform, there is no public pricing or free trial — engagement requires direct contact with the sales/scientific team.
- Mutagenesis Assay Transition: The DuplexSeq™ Mutagenesis Assay is now owned and operated by Scantox, which may create uncertainty for existing customers regarding support and continuity.
Frequently Asked Questions
What is Duplex Sequencing®?
Duplex Sequencing® is TwinStrand's proprietary NGS error-correction technology that independently sequences both strands of a DNA molecule and compares them to eliminate sequencing errors, achieving error rates as low as 1-in-10 million — roughly 10,000× more accurate than standard NGS.
What is the AML Assay used for?
The AML Assay is designed to detect acute myeloid leukemia–related mutations with 100-fold higher resolution than conventional sequencing, making it particularly valuable for measurable residual disease (MRD) monitoring to track treatment response and relapse risk.
Who is TwinStrand Biosciences designed for?
The platform serves oncology researchers, clinical scientists, pharmaceutical companies conducting regulatory mutagenicity studies, toxicologists, and any researcher who needs to detect low-frequency variants beyond the sensitivity of standard NGS methods.
What happened to the DuplexSeq™ Mutagenesis Assay?
TwinStrand's DuplexSeq™ Mutagenesis Assay is now owned and operated by Scantox. Customers interested in that assay for genotoxicity and mutagenicity testing should visit Scantox's platform directly.
Can I get a custom sequencing kit?
Yes. TwinStrand offers both off-the-shelf kits for immediate use and custom kit development through collaboration with their scientific team, allowing researchers to adapt Duplex Sequencing to specific sample types and research questions.
