However, from the onset of the project, Key Tech set out to establish guidelines for an area where they often see issues: the interface points between each partner. Bridging the interfacesĭeveloping a product with a large group of multiple partners can be challenging if not executed well. The success of the ePlex® development began with the tight-knit collaboration between the Key Tech and GenMark teams. For example, miniature heaters developed through thermal analysis allow for localized PCR on the cartridge, and magnetic actuators allow the manipulation of beads for biologic capture.ĭevelopment proceeded in accordance with IEC 61010 for hardware and IEC 62304 for embedded firmware, culminating in full-scale device verification and transfer of design for manufacturing. In addition to the circuitry, Key Tech designed mechanisms for making electrical, pneumatic, and mechanical actuator connections.įirmware architectures were created from the ground up to synchronize the system. GenMark’s proprietary eSensor® Technology is an electronic DNA detection technology. Behind the scenes lies an architecture of specialized printed circuit boards, custom firmware, and electromechanical actuators, which drive innovative technologies, including electrowetting and GenMark’s proprietary eSensor® electrochemical detection.Įlectrowetting, a process of using circuit control to “motivate” microliters of fluid using only electricity, is driven by custom-designed Key Tech circuit boards. Ultimately, Key Tech worked collaboratively with multiple partners to develop a system that, from the outside, contains a large touchscreen, barcode scanner, and multiple cartridge loading slots. ![]() Heavy R&D had to go into figuring out, how can you make one circuit board that can serve both of these technologies properly? To this day, one of the greatest accomplishments of Key Tech and GenMark on this product was creating a design where both eSensing and electrowetting can live within a few millimeters of each other, and they both function properly. Key Tech took an upfront de-risking approach, considering how fluidic control, temperature control, and manufacturing risks could be mitigated early in the design process. While both technologies were founded and operated on printed circuit boards, individual coding systems, special surface coatings, and proprietary aspects down to the molecular level created many technical challenges for combining the technologies onto one cartridge. In the early stages of development, GenMark tasked us to incorporate novel electrowetting sample preparation technology with their proprietary electrochemical detection technology to ultimately create the next generation product: GenMark’s ePlex® System. – Brian Murphy, Key Tech project manager on the GenMark ePlex® System. ![]() ``What I loved about the GenMark project was we could take some of the most complex and advanced technology out there and make it so accessible to users.`` The result: ePlex received a 2017 MDEA Award, and was recently adapted to aid in the detection of SARS-CoV-2 during the Coronavirus pandemic. ![]() Over several years, we collaboratively translated nascent electrowetting sample prep technology that worked in concert with GenMark’s e-Sensing technology into an integrated, commercialized product. Key Tech was proud to play a role in the multi-partner team that brought this technology to life via phases of design, prototyping, testing, verification, and manufacturing transfer. The goal for the development program was to create a next-generation diagnostic platform that could accomplish complex tests while making it incredibly simple for the user. GenMark’s ePlex® System is a state-of-the-art sample-to-answer molecular diagnostic test for infectious diseases.
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