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Next-Generation DNA Sequencing System | Class II IVD Manufacturing | Ascential
Developing a Scalable Next-Generation Sequencer with Proprietary Chemistry
Integrating Complex Subsystems for Class II IVD Compliance
A leading life sciences company needed a fully automated, high-precision sequencing system capable of handling sensitive reagents, managing complex multi-channel fluidics, and integrating third-party components for efficient sequencing based on proprietary chemistry. The system had to support strict regulatory compliance for Class II IVD and IEC 61010 requirements without compromising speed, scalability, or performance. Ascential engineered and integrated the platform’s fluidics, motion control, electronics, software, enclosure, and monitoring systems to create a scalable sequencing instrument designed for reliable long-term commercialization.
Fluidic manifold with integrated pump and valve delivery
15-Channel0
Registration precision of self-guiding flow cell handling system
25µm0
Through integrated program management, testing, and design for manufacturability
Faster Time-to-Market0
The Challenge
DNA sequencing is advancing faster than ever, and companies developing novel sequencing platforms must move quickly without compromising precision, reliability, or regulatory readiness.
The client needed to develop a next-generation sequencing system based on proprietary chemistry for DNA sequencing. The platform required fully automated, high-precision handling of sensitive reagents, complex multi-channel fluidics, and integrated third-party subsystems across fluidics, optics, motion control, thermal management, electronics, and software.
The system also needed to adhere to strict Class II IVD and IEC 61010 regulatory requirements, requiring a development partner capable of supporting both technical complexity and compliance from the earliest stages of the program. They had several key goals for the project:
Manage Sensitive Reagents and Flow Cell Handling
Ensure accurate reagent delivery, controlled fluidics, and precise flow cell registration within the sequencing workflow.
Synchronize Complex Subsystems
Integrate fluidics, optics, motion control, electronics, software, and third-party components into a single reliable platform.
Design for Class II IVD and IEC 61010 Requirements
Build a system architecture, enclosure, and controls strategy designed to support safety, reliability, and regulatory expectations.
Accelerate the Path to Market
Reduce handoff risk, late-stage redesigns, and integration delays through end-to-end program management and development ownership.
Ascential's Solution
Ascential engineered a 15-channel fluidics manifold with integrated pump and valve delivery systems to manage precise reagent handling. Additional consumable handling and filling stations were designed to support reagent cartridge production and use within the sequencing process.
The team paired this fluidics architecture with a self-guiding flow cell handling system capable of 25µm registration accuracy, along with a self-aligning, automated flow cell fluid interconnect to support ease of operation and repeatable performance.
Ascential also developed and implemented fluidic imaging controls, power distribution electronics, and real-time monitoring tools to ensure reliable power management and system visibility. A robust enclosure and frame were designed to house the integrated subsystems, supporting durability, operator safety, and compliance.
Because the platform depended on multiple third-party components, Ascential synchronized external motion, optical, and thermal systems across the full instrument architecture. By owning full-system integration, hardware design, software design, prototyping, verification testing, and value engineering, Ascential helped eliminate handoff risk and create a cohesive sequencing platform built for performance and scalability.
Technical Capabilities Delivered
The sequencing platform required the integration of multiple complex subsystems into a single automated instrument.
Capability
What Ascential Built
Fluidics
Custom 15-channel fluidics manifold with integrated pump and valve delivery systems
Precision Motion Control
Self-guiding flow cell handling system with 25µm registration accuracy
Reagent consumable cartridge and supporting fill/handling architecture
Electronics
PCAs for fluidic imaging control and power distribution
Software & Monitoring
Real-time monitoring tools and integrated system controls
Enclosure Design
Electrical, fluidic, and structural enclosures designed for durability, operator safety, and compliance
System Integration
Full-system integration across fluidics, optics, motion, thermal management, electronics, and software
Key Results
Ascential transformed a complex sequencing concept into a fully integrated, high-precision instrument platform designed for reliable performance and long-term commercialization.
Delivered seamless integration of fluidics, optics, electronics, software, motion control, and thermal components
Achieved 25µm registration precision through self-guiding flow cell handling and automated fluid interconnects
Engineered a 15-channel fluidics manifold with integrated pump and valve delivery for precise reagent handling
Accelerated time-to-market through end-to-end program management, design for manufacturability, integrated testing, verification, and value engineering
Why It Matters
DNA sequencing is advancing quickly, and companies that bring novel platforms to market efficiently can set the standard for performance, usability, and scalability. But moving from proprietary chemistry to a compliant, production-ready sequencing system requires more than discrete engineering support. It requires a partner who can own the full lifecycle without handoff risk.
Ascential’s integrated approach meant fewer surprises, fewer delays, and a stronger path to commercialization for a next-generation sequencing system built around complex proprietary chemistry.
Accelerate Development of Complex Sequencing Platforms
Ascential helps life sciences companies translate proprietary chemistry, complex fluidics, precision motion, and regulatory requirements into scalable instrument platforms built for commercialization.