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The global health care sector has changed significantly in the last three decades and it continues to rise to the new challenges presented by the ongoing pandemic. COVID-19 has thrown diagnostics on center stage since the onset of the pandemic.

The result has been those terms such as “PCR test” and “false negative result” are no longer terms confined to the conversations of healthcare professionals, they are understood by increasing numbers of the public too.

Consequently, it is commonly accepted that the successful deployment of these tests in the right setting, is the key to mitigating the socio-economic impact of future outbreaks, but also to improve global health more broadly. Timely diagnosis is essential to the identification and effective management of a disease.

Lack of access to testing and late intervention may increase the incidence and severity of other diseases too such as tuberculosis, diabetes, HIV/AIDS, hepatitis C, and hypertension. Hence, diagnostic care is a critical factor in the achievement of universal health coverage.

However, the diagnostic process is a complex one that involves clinical reasoning and information gathering to determine a patient’s health problem and/or severity of the disease. An ineffective diagnostic can result in sub-optimal patient management outcomes that can have a serious impact on a patient’s prognosis and quality of life.

Timely effective diagnostic care is vital to contribute to the growing momentum for change in this crucial area of healthcare quality and safety.

This is where miDiagnostics shines in the spotlight as a company that is setting milestones by offering excellent solutions in the healthcare industry. The company is empowering healthcare professionals by providing diagnostic tools that offer a new and disruptive approach to current testing methods.

Under the leadership of Katleen Verleysen, CEO, the miDiagnostics team bring together research and business expertise, coupled with a passion to see their solutions bring significant positive change in the global healthcare market. Expressing her views, Katleen shared, “I truly believe that the right team can make a difference!”

Continuum of excellent services

miDiagnostics was founded in 2015, out of imec (Belgium), a leading R&D center for nano and digital technologies in collaboration with Johns Hopkins University.

With the recent recruitment and strengthening of its commercial expertise, miDiagnostics is now ready to impose its ambitious mission of providing a comprehensive range of health screening tools that will eventually grant diagnostic access to everyone, everywhere and at any time.

The decentralization of diagnostic testing is not a new market trend. However, limitations in sample and testing technology have resulted in slow progress in this phenomenon. miDiagnostics plans to demonstrate its ability to innovate by addressing and overcoming these historical challenges with ‘silicon chip technology near-patient testing.’

In fact, the miDiagnostics mission is not only to support testing in near-patient use cases but to eventually take the accuracy of the accurate diagnostic tests into the home setting.

An Exceptional Leadership

Katleen Verleysen has been in life sciences (mainly the diagnostics sector) for over 20 years. After a PhD in analytical chemistry (University of Ghent, Belgium), Katleen moved to the USA for a postdoctoral fellowship at the Medical Center of Duke University (NC, USA).

This was her first opportunity to embrace the innovation being delivered in an academic environment and create from it a commercial and viable business. Success on this project was cemented with the subsequent acquisition by Pfizer.

Thereafter Katleen returned to Europe, participating in multiple startup company projects, and occupying several C-level global roles.

“I joined miDiagnostics in May 2021 to take the company from research into a commercial entity. This is the most exciting and promising project I have been involved in. As CEO of miDiagnostics, I am delighted to say that we are still on track to launch our new platform by the end of April 2022. We feel the strength in this product’s current and future capabilities will likely make it the most positive, disruptive introduction to the diagnostics industry for a long time.” Katleen stated.

The challenges involved in turning a diagnostic test from concept to product cannot be underestimated. Many R&D projects come to a premature end because issues in translating a laboratory concept into a commercial product make it impossible to come to fruition. However, the most successful players in this industry have been the ones to find solutions to the challenges that would stop others from going any further.

These challenges have been no different for miDiagnositcs. In fact, even more so. Many attempts have been made to evolve the molecular test into the perfect blend of accuracy and utility in near-patient settings. This has been amplified especially during the pandemic.

But the perfect solution remains elusive and is regarded by many industry experts to be the holy grail of diagnostic tests.

“We firmly believe that miDiagnostics can achieve this, and more, with its upcoming product launch,” she expressed.

Overcoming the Hardships

However, Katleen was quick to point out that innovation alone is no guarantee of business success.

Innovation needs to deliver functionality that addresses real market needs. Even then, innovation is not helpful if you are having to sacrifice product strengths in other areas such as clinical performance or having to extract more invasive sample types from your patient. Finally, the financial cost needs to be practical and justifiable.

All of these factors need to be taken into consideration simultaneously during the product development phase to ensure everything is aligned to the same outcome objectives.

“The support of your investors is also imperative on this journey. Success in this industry is not immediate, and true innovation takes time to deliver. So, patience and belief in the project and the outcome is crucial during that early phase before a company’s first product launch.

Technology as a revolution

While sharing her opinion Katleen said, “The pandemic has clearly exposed the flaws in our healthcare system. We were simply not capable of screening large populations on a recurrent basis for accurate and sensitive detection of SARS-CoV-2.  Neither were we able to provide a fast turn-around-time for test results (i.e., in 24 hours or less).”

Furthermore, diagnostic capacity was impaired by the inevitable strain on supply chains. The consequences were devastating, resulting in many people having to wait days before a test was made available to them. There had never been a situation of such overwhelming demand for diagnostic testing and even the world’s most sophisticated healthcare systems had no contingency for this level of demand.

Nevertheless, the pandemic did accelerate the development of novel technologies. She further said, “For me, the current market drivers for successful adoption of diagnostic technologies are that they must exhibit:

Accuracy – best possible sensitivity and specificity.

Portability– close to the true point of need.

Scalability – designed for manufacturing / straightforward assembly.

Affordability – accessible to everyone.

Surmounting the Challenges

Katleen has shared her experience about how miDiagnostics has had to overcome challenges— “It was indeed a time when we had to be extremely creative to keep our projects on track. We were also heavily reliant on our outsourcing partners.

Thankfully, careful due diligence on our part meant we were able to select strategic partners for outsourcing that did everything they could to ensure our projects remained on track or that any delays were minimal. We are indebted to them for their commitment to helping us achieve this.”

We did suffer some delays in commercial rollout, but this was largely down to regional COVID-19 restrictions which meant we were unable to support the installation of equipment with on-site training and engineer presence as we would normally. However, our ability to adapt in this situation, and embrace the remote learning programs that are a common feature of our lives today meant the delay to these projects was minimal. We even abandoned our traditional working week approach and began offering our clients training at weekends where this was needed.

In addition, our office and lab-based teams had to observe the restrictions themselves. To overcome this, lab personnel worked in shifts to allow for good social distancing without losing lab development time.

Being proactive in terms of risk analysis and early procurement of items with long lead times helped alleviate shortages. The Suez Canal incident compounded the already difficult problem relating to global supply of electrical components! Even as the effects of the pandemic begin to subside, vigilance in supply chain shortfalls continues to be a crucial daily activity.

“Without all the local support, we would not be where we are today,” she said.

The same holds true for the relentless support of the company’s investors (all family offices), who did another capital injection of 50M EUR to accelerate the developments and a 20M EUR loan from the European Investment Bank (EIB) to scale-up production to millions of tests.

Enlightening the entrepreneurs

“The key for success is a market–money–team,” remarked Katleen Verleysen when asked about what advice she would like to give to budding entrepreneurs and enthusiasts aspiring to venture into the healthcare services space. “Start from what the market is telling you it needs, and not from technology that sounds great! Make sure the company is well funded with investors that will support the company throughout its entire journey and realize that the team can and will make the difference!” she added.

Towards success

“2022 will be an exciting year for miDiagnostics with the launch of our very first product: an ultra-fast and portable RT-qPCR SARS-CoV-2 test,” Katleen said. RT-qPCR is and will remain the gold standard for molecular testing for the foreseeable future and although this team started with a COVID-19 test, miDiagnostics will continue to build on its portfolio, which will include (but not limited to) solutions for influenza A/B, RSV, as well as sexually transmitted diseases.

We are also excited about introducing the ability to perform some of these tests on the exhaled breath. This was deemed not possible during the pandemic as the drop in product performance made the sample type incompatible with screening.

We will show that not only can it work for screening of various biomarkers, but that it will revolutionize the patient sample collection experience that would otherwise remain uncomfortable, intrusive, and occasionally painful. A true game-changer.

Next to the PCR product line, miDiagnostics is also working on portable cellular diagnostic devices, which could ultimately be used in the home setting (i.e., CBC monitoring). This is a technology, with silicon chips at its core, which includes a nanofluidic processor for blood sample preparation and lens-free imaging for cell counting and characterization.

Exhibiting Excellence

“Testing has been crucial for the restart of travel and, although we would prefer for it not to be needed anymore, it still remains key today. That is why we were delighted to collaborate with miDiagnostics with the pilot of their PCR-testing solutions at Brussels Airport. Their innovation in the utility of PCR tests is exactly what we look for as an airport offering testing services: fast, scalable, and reliable.”

“And the breathalyzer will make testing even more comfortable and less invasive in the future. This pilot allowed the miDiagnostics team to experience what testing is like in a fast-paced, 24/7 active environment, which gives us the confidence that their testing set-up can adapt to this type of setting. We look forward to being able to structurally offer our passengers the benefits of the miDiagnostics PCR-tests at the Brussels Airport Covid-19 Test Centre.”

– Margot Lenoir, Chief of Staff to the CXO, Brussels Airport Company