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About This Project

Thermo Fisher Scientific

Purification Instrument for the Ion Torrent Genexus™ System

Thermo Fisher engaged Key Tech to rapidly develop a nucleic acid Purification Instrument to provide upstream sample prep for the Genexus™ Next Generation Sequencer (NGS).  The Ion Torrent Genexus™ System (Purification Instrument + NGS Instrument) is capable of single-day turnaround from specimen sample to report with only ten minutes of hands-on time. The Purification Instrument developed by Key Tech extracts and purifies DNA and RNA from a variety of biological input samples with minimal user interaction by using magnetic particle handling, automated pipetting, and thermoelectric heating. The Purification Instrument quantitates the resulting purified nucleic acid using fluorometric technology and Qubit™ reagents. In addition to providing upstream sample prep for Thermo Fisher’s Genexus™ NGS, the Purification Instrument can be deployed as a standalone laboratory device.

The Purification Instrument was developed under full design controls, and in compliance with applicable regulations, such as ISO 14971 (risk management), IEC 62304 (software development), and IEC 62366 (usability engineering). Key Tech worked with Thermo Fisher stakeholders to generate product requirements and define the workflow, taking into consideration customer needs, user research findings, and lessons from related laboratory instruments. In order to meet automation and ease of use objectives, the instrument includes a vision system for detecting consumable status and reporting near real-time information to the user during consumable loading and unloading. Key Tech worked with Thermo Fisher to design a pre-filled reagent consumable in order to eliminate a number of tedious user preparation steps required by other instruments. The automated pipette module is capable of accessing all deck locations by means of an x-y-z gantry, and can accurately dispense volumes down to 2ul. High-level instrument control is accomplished by a single board computer running a Linux OS, low-level functions are performed by an embedded microcontroller, and stepper motors are controlled by multiple FPGAs. The user interface screens were developed by Key Tech’s design team after collecting input from Thermo Fisher’s marketing team, scientists, and R&D group. Instrument and graphical interface design languages were implemented consistent with Thermo Fisher’s corporate brand guidance.

Key Tech created benchtop hardware to assess technical risks before moving forward with full instrument development. The development scope involved all Key Tech disciplines – program management, electrical, mechanical, and computer engineering, and industrial design. Key Tech’s technicians and engineers sourced components, built seven prototypes, and performed checkout and characterization testing all on-site in Baltimore. Mature prototypes were delivered to Thermo Fisher’s research scientists to support assay development, and the instrument design package was transferred to Thermo Fisher engineers for commercialization.

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