The MYKEE is a multi-purpose molecular DX platform which hits the sweet spot between lab-quality and speed. It can do lab quality tests at home in less than 20 minutes. A simple and fast workflow is ensured by the MYKEEs intuitive user interface.

The making of MYKEE

Initiation: Covid

MYKEE originates in the Covid pandemic, when Micronit founder Ronny van ‘t Oever intended to contribute to controlling the spread of the virus and initiated a collaboration between 5 local companies. Their shared expertise has allowed us to develop this point of use platform, hardly unchanged from the vision that Ronny had at the time. Micronit coordinated the project and was responsible for the design of the disposable microfluidic cartridge, as well as the integration and testing of all platform components. The biochemical reaction detecting SARS-CoV-2 RNA was developed by NYtor, an assay developer located in Nijmegen. Several isothermal amplification reactions were investigated, with LAMP (loop-mediated amplification) giving the best results. The reader was designed by D’Andrea & Evers (Enschede), the electronics were made by Elect High-tech Electronics (Weerselo), who hired Leap Development (Deventer, since acquired by Demcon and called Demcon Electronics) to design the PCB and develop the firmware of the reader. The last partner, Holland Innovative (Enschede) assisted with development conform IVDR.

Continuation: other applications and commercialisation

The development of the platform was largely finished around the end of the pandemic, when the original application was no longer very relevant. We therefore performed many compatibility tests with other assays from various developers. Many were LAMP-based assays, but also other isothermal amplification reactions (e.g. RPA), as well as Crisp-Cas or combined LAMP+Crispr-Cas assays have proven to be compatible with the platform. Building on these results, the first product to market is currently undergoing the final validation.

Future: revisiting diagnostic tests

As the MYKEE platform is designed for diagnostic applications, the development has been performed following ISO13485-based processes. The first application is not diagnostic test, but still furnishes us with valuable initial usage data and user feedback, which can be considered when expanding the applications into the IVDR field.

We offer MYKEE to institutes and commercial entities looking to transfer or develop an assy for point of use. Potential applications include agricultural, quality control, veterinary and diagnostic tests. Parties interested in developing a diagnostic assay for point of use enabled by the MYKEE platform are therefore very welcome to inquire into the options.

The MYKEE platform

Micronit’s 6-well cartridge

This cartridge contains up to 6 independent wells for reagent deposition, and multiplex capacity of 6 to 12 separate targets from one sample. It has an easy and reliable filling using a manual single-action step. It is low-cost and user friendly by design. The cartridge layout can be adjusted to specific goals.

Reader and app

The reusable reader has a small footprint and is low in weight. The reader has multiplex capability with 6 independent positions with each position featuring:

• A heater and temperature sensor
• 4 LEDs
• A multispectral optical sensor

All 6 positions are independently configurable. Furthermore, the reader is battery-powered and rechargeable by USB-C.

The app has a simple user interface, and guides users with step by step instructions for use. Controlling the reader works via the app. Data processing and the database itself are cloud-based, also controlled by the app.