One Lambda Devyser Accept cfDNA Assay

Reliable donor-derived cell-free DNA (dd-cfDNA) detection by Next Generation Sequencing (NGS)

The One Lambda Devyser Accept cfDNA Assay is an advanced, CE-IVD marked NGS solution for monitoring dd-cfDNA in solid organ transplant recipients. Designed for use with Illumina platforms, this simple assay ensures sensitive and accurate detection of dd-cfDNA, enabling earlier detection of allograft injury, with a limit of detection of 0.1%.

This all-in-one solution offers an integrated workflow: PCR amplification, sample indexing, and sequencing-ready library prep with less than 45 minutes of hands-on time. The intuitive Advyser Solid Organ software rapidly and automatically calculates % dd-cfDNA from sequencing data, ensuring robust, reproducible results with minimal user interaction required. This 1-day workflow means that standard and urgent reporting timelines are easily met, supporting timely, clinical decision-making.

Key Features and Benefits:

• Unrivalled sensitivity (0.1%) compared with other Illumina-based vendors; critical for cardiac transplantation
• Superior specificity using 50 population-independent indel markers for accurate discrimination of informative markers
• Post-transplant monitoring of two genetically distinct organ donors
• Simple workflow with few manual steps and ready-to-use reagents
• Next day results
• Excellent batchability with 96 unique barcode indexes
• Ability to pool libraries for One Lambda Devyser Accept cfDNA and Chimerism, with universal indexing reagents, workflows, and thermal cycler programs
• Ability to combine with One Lambda AllType FASTplex (HLA) library for added flexibility
• Devyser calculator tool to maximise Illumina reagents
• Automated, user-friendly software for intuitive interpretation and reporting

White paper & Comparative Literature Review

‘Microchimerism Matters: Advancing HSCT Monitoring Through NGS’

White paper

‘Improving The Efficiency And Reliability Of Post-Transplantation Monitoring And Prognosis’

Workflow summary:

• Sample Collection & DNA Extraction: Pre-transplant genomic DNA from donor and recipient and post-transplant cell-free DNA from recipient
• Multiplex PCR Amplification: Targeting 50 indel markers in a single reaction
• Library Preparation: Rapid, sequencing-ready library using universal reagents
• NGS Sequencing: Compatible with multiple Illumina platforms and reagents
• Data Analysis: Automated, intuitive software for dd-cfDNA calculation, monitoring and reporting

(Requires credentials for the One Lambda™ Customer Portal)

Unlock earlier, smarter intervention in transplant care. With highly sensitive donor-derived cell-free DNA (dd-cfDNA) detection, you can spot allograft injury or rejection sooner, enabling personalised immunosuppression, reducing unnecessary biopsies, and dramatically improving patient experiences and graft outcomes. When dd-cfDNA levels are stable, patients avoid invasive procedures. When they rise, you act fast. Precision monitoring for patient assurance.