GenMark’s ePlex® System

GenMark’s ePlex® System is a state-of-the-art sample-to-answer molecular diagnostic test for infectious diseases. 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.

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. 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.

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.

The Challenge

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.

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.

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.

Another challenge that Key Tech had to address was ensuring that using the cartridge was simple because GenMark prides itself on creating devices Designed for the Patient, Optimized for the Lab®. Key Tech focused heavily on usability from the very earliest stages of development, evaluating the form factor of the cartridge and device, to make the technology as easy to use and error proof as possible.

Capabilities used

Key Tech was the perfect partner for GenMark due to our ability to simultaneously solve complex technology challenges such as fluidics and temperature control, and design for the end user, while also following ISO 13485 product development procedures. Capabilities used include:

• Mechanical Engineering
• Electrical Engineering
• Computer Engineering
• Systems Engineering

Solutions used

• Technology Assessment
• Subsystem Development
• End-to-End Product Development

The Key

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. 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.

Electrowetting, a process of using circuit control to “motivate” microliters of fluid using only electricity, is driven by custom-designed Key Tech circuit boards.

GenMark’s proprietary eSensor® Technology is an electronic DNA detection technology.

In addition to the circuitry, Key Tech designed mechanisms for making electrical, pneumatic, and mechanical actuator connections.

Firmware architectures were created from the ground up to synchronize the system. 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.

Development 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.

The Solutions

The success of the ePlex® development began with the tight-knit collaboration between the Key Tech and GenMark teams.

Bridging the interfaces

Developing a product with a large group of multiple partners can be challenging if not executed well. 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.

To keep the project seamlessly moving forward, Key Tech created an interface specification document to ensure those joints – whether physical, electrical, or software – always had a smooth handoff.

The teams were able to build dozens of prototypes for day zero panel testing. The electromechanical design iterated in lock-step with the panel design. Embedded software features were updated, and new versions were distributed over Ethernet with short turnaround.

Creating a fitting solution

The team used every millimeter of space to fit all the electrical connections, pneumatic connections, heating components, and magnets into a cartridge that is the size of a smartphone.

The final product nests all of these essential elements together, includes all of the chemicals and enzymes required for the assay testing, and provides enough room for them to actuate. The only thing needed from the lab is the sample.

Making the complex, simple

While the science taking place in the cartridge is cutting-edge, GenMark’s ePlex® system showcases how complex technology can be made approachable for users in a simple to use platform.

To reach that goal, the development team had to think through every possible scenario:

• Do I have to keep the cartridge perfectly level to have a valid result?
• Can the user insert the cartridge backward? Upside down?
• What happens if the user only slides the cartridge in ½ or ¾ of the way into the instrument?

They also had a big picture question to answer: how do we take the technological burden off of the users?

In order to anticipate potential user challenges, the team developed a self-check system that runs when the instrument turns on and powers up. The user isn’t aware of these start up diagnostic tests, but the system will flag issues and in some cases auto-correct errors.

The Results

GenMark’s ePlex® System is the culmination of hard work and thoughtful design, which has led to incredible results. Not only is the ePlex® System enabling better patient outcomes and driving lab efficiency, it is also positioned to scale and manage testing demands.

2020 Highlights*

• 95% revenue growth
• 265 ePlex® analyzers placed in 2020
• $10M anticipated cash flow from operations
• >75% increase in monthly ePlex® consumable capacity
• *Information published in January 2021 based on the last full year of data.

GenMark ePlex® Highlights

• More than 6,000 devices sold through the end of 2020.
• The ePlex® BCID cartridges offer the broadest coverage of organisms and resistance genes for BSI/Sepsis diagnosis.
• The ePlex® RP2 cartridges identify 20+ viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2.
• Was acquired by Roche in Q2 of 2021 for approximately $1.8 billion.
• Earned a Medical Device Excellence Award in 2017.

The ePlex® system is currently CE marked, 510k approved, and EUA approved for COVID-19 testing and is available for commercial sale.

GenMark®, GenMark Dx®, ePlex®, GenMark ePlex®, eSensor® are trademarks of GenMark.