Leuven, Belgium-based Midiagnostics NV, which is looking to bring miniaturized, rapid, blood-based tests with built-in connectivity to both patients and clinicians, reported the completion of a €14 million (US$15.4 million) investment round. The company intends to use the funds to speed the development of its nanofluidic processor on a chip and prepare it for industrial-scale manufacturing.

The round was supported by existing shareholders, as well as leading life science and tech investors Rudi Pauwels and Urbain Vandeurzen. Pauwels and Vandeurzen join the existing investors and serial entrepreneurs Marc Coucke and Michel Akkermans, as well as the technology founders Imec and Johns Hopkins University (JHU).

“The continued commitment of our founding partners Imec and JHU, our existing shareholders and this latest endorsement by two highly successful serial entrepreneurs further strengthens our confidence in the future of Midiagnostics,” said Nicolas Vergauwe, CEO of Midiagnostics. The company’s technology was invented by Imec, an R&D and innovation hub in nanoelectronics and digital technologies in Belgium, and Baltimore-based JHU.

Vergauwe told BioWorld that the company, which was founded in 2015, is aiming to make diagnostic information as accessible and readily available as intelligence obtainable via a smartphone. He added that, in general, “we have the world at our fingertips, but the diagnostics space is bound to centralized lab facilities. That presents an issue when a fast diagnosis is required, such as in the case of COVID-19.”

Another challenge is that physicians still are relying on tools they used 30 years ago, Vergauwe continued, such as stethoscopes or thermometers. As a result, it is at times difficult to determine whether an infection is viral or bacterial.

To help physicians and patients alike, the company is developing a silicon chip technology, also known as its nanofluidic processor. With its built-in connectivity, testing can be brought directly to all parties. As a result, those undergoing chemotherapy, for example, can test themselves at home – an ideal situation, given the weakened immune systems of these individuals. The data then can be shared with the person’s oncologist via the cloud.

Silicon chip

The unique aspect of the company’s offering is this silicon chip, as it miniaturizes to the size of a square centimeter all of the lab processes that currently are performed on big machines. The chip is being built into a test card, which is roughly half the size of a credit card. That test card fits into a small reader, which is akin to a credit card reader seen in retail stores.

Of note, sample preparation prior to analysis happens inside the chip. Then, the readout of the biomarker is done via the reader. In addition, the company’s tech aims to measure just about any biomarker in the human body, from cells, to nucleic acids, to proteins.

It likely will take a couple of years to get to market, as the company is switching modes from R&D into product development. A validation will be needed, and that means testing in labs worldwide, as well as with patients at home. Once that data package is in hand, the company plans to go to regulatory authorities. While the U.S. and Europe are targets for this technology, the company hopes to go beyond Western markets to help, for example, community care centers in Africa.

Multiple programs

The company is running two programs, one of which will lead to a product for complete blood cell counting. One application of this product would be monitoring the immune system of cancer patients who receiving chemotherapy.

While that is the most advanced program, the other one will focus on infectious disease testing. This molecular diagnostic test will measure the genetic material of viruses and bacteria from swabs or drops of blood. Vergauwe highlighted tropical fever, which can be caused by a range of viruses. For that reason, it is hard to identify the precise cause of the disease. Diagnosing a patient can involve the use of multiple tests, thereby incurring costs. The company wants to offer these tests via one card from the same sample.

This has implications with conditions such as COVID-19, as patients initially were complaining of a range of generic symptoms, such as respiratory issues and muscle pains, that are caused by multiple diseases.

Midiagnostics also reported in 2019 that Imec received NASA funding to test a technology for monitoring astronauts’ health status under zero gravity conditions using a first-of-its-kind disposable diagnostic device developed by the company.