MODAPLEX Technology

Comprehensive multi-biomarker testing

Modern management of complex disease, like in oncology and cancer care, relies heavily on biomarker testing for diagnosis, selection of effective therapies, and treatment monitoring. As the number of actionable biomarkers continues to increase, serial single-gene testing has become less practical due to its large specimen requirements, long turnaround times, and cost- & labor-intensive bioinformatic data analysis. There is a rising need for more advanced technologies enabling multi-gene testing as a new standard of care. A multi-gene testing approach helps to ensure capturing all relevant biomarkers at once, making the most of limited sample tissue while also decreasing critical turnaround times.

Despite the overwhelming need for multi-biomarker testing, many clinicians and pathologists rely on outsourcing this service to specialized reference laboratories, leading to long turnaround times for results, and potentially suboptimal treatment decisions. The MODAPLEX platform automates multi-gene testing into a consolidated workflow with turnaround times of 4 hours. This allows hospitals, clinics, and molecular pathologies to bring this valuable technology in-house, facilitating faster results and better coordination of care.

The MODAPLEX platform is a benchtop system for molecular profiling and comprehensive multi-biomarker testing. With little hands-on time and a simple workflow, up to 48 reactions can be processed with 4 hours turnaround time. Detection, differentiation, and if needed quantification of all clinically relevant genetic alterations can be consolidated onto one platform. That makes MODAPLEX ideal for multi-gene testing and analysis of biomarker signatures.

MODAPLEX is available as closed system with a defined assay portfolio, as well as an enabling platform to customers interested in developing and commercializing their PCR multiplex and multi-marker assays of interest.

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Workflow automation for multi-biomarker testing

The MODAPLEX System merges polymerase chain reaction (PCR) and capillary electrophoresis (CE) into one automated workflow. This technology merge enables the analysis of multiple molecular markers in a single workflow under routine settings. Each MODAPLEX PCR reaction consists of multiple primers and probes unique for a specific set of targets. Through high-level multiplexing and parallelized analysis of various genetic alterations (e. g. mutations, gene fusions, copy number variations), MODAPLEX allows every lab to detect actionable biomarker in a simple and cost-effective workflow.

During the PCR cycle, the fluorescently labeled PCR amplicons are continuously injected into the capillary gel. There, they are separated based on their physical properties and subsequently detected after passing through two lasers. This process is repeated over several PCR cycles during a MODAPLEX run, generating real-time data for each well and each target.

The MODAPLEX load-and-walk-away workflow is identical for all tests and combinations of tests. The workflow comprises three steps: PCR set-up, MODAPLEX run, and data analysis. Results are evaluated with the MODAPLEX Reporter software. The MODAPLEX Reporter provides automatic import of acquired data from the MODAPLEX device, along with the analysis and summary of results in a comprehensive report.