Katleen Verleysen: Enabling Decentralization of High-Quality Diagnostics

Katleen Verleysen

Finding the light within herself to assist the growth of numerous companies through the unique hurdles associated with science start-ups, Katleen Verleysen shines bright. Beginning her journey in the life sciences industry, she primarily spent over two decades in the diagnostic sector.

Today, as the CEO of miDiagnostics, Katleen contributes her expertise and efforts to evolve the company from research into a commercial entity by launching its first product: the ultrafast and portable COVID-19 RT-PCR Test. However, in her new endeavor, Katleen focuses on mitigating several obstacles for the transition to succeed.

So, where does the motivation lie for the leader to tackle challenges, understanding that it’s a significant task?

Let us unveil her journey in depth!

The Early Roots

After gaining a PhD in analytical chemistry from the University of Ghent in Belgium, Katleen moved to the US, taking a postdoc position at the Medical Center of Duke University in North Carolina. She shares, “That was a truly wonderful experience for me because the technology we worked on was spun out into a start-up company, which Pfizer then acquired. After such an encouraging kickoff, I was hooked!”

Katleen stayed in the start-up sphere, moved back to Europe, helped launch several companies, closed exits and took on many C-level and BoD roles in Europe and the US. She finds the challenge of growing a company hugely rewarding, keeping her motivated through ups and downs.

Empowering Healthcare

Since joining miDiagnostics in May 2021, Katleen has put forth the effort to have many disciplines seamlessly working together, requiring people with the right skills in the right place to collaborate in an agile, flexible, and dynamic way. She adds, “We need to support these superstars with advanced agile project management and sufficient financial bandwidth to provide them with the elements they need to prosper.”

miDiagnostics’ vision is to bring fast, affordable, scalable, and accurate diagnostics closer to the point of need. It intends to make PCR testing available on location, whether a satellite laboratory, an airport, a pharmacy, or even a home setting. She states that when it comes to molecular diagnostic tools, PCRs are still the golden standard, with the highest sensitivity, specificity, and versatility. But society is currently hampered by the practical limitations of current PCR technology, including the need to send samples off to a centralized lab, which increases the logistical complexity of testing and delays results.

“We envisage a future where these limitations are overcome, and PCR technology can be used on the spot, which we believe will shape the future of healthcare for the better,” Katleen clarifies.

Grasping the Experience

Katleen’s experience in running start-ups has been very insightful in building a company with a huge potential for impact in the diagnostic market. She mentions, “Over the years, I’ve learned what needs to be done, but even more importantly, I’ve learned which mistakes to avoid. One of the key things is creating momentum and then keeping that up – I truly believe it is better to make a wrong decision than no decision, as a poor choice still opens up the path for progress and improvement.”

Katleen believes one of the key elements to a strategic approach is a thorough understanding of how the market functions. It allows you to work in reverse, starting with what solution is needed and in which setting, and then figuring out the path to take you there:

Which sales channels will you have at your disposal?

How will you be able to differentiate yourself from the competition?

How will you obtain regulatory approval and ensure reimbursement?

How long will it take to develop your innovation, how much will it cost, and do you have a solid IP position?

It is vital to consider the whole picture from the start instead of developing technology and then looking for a solution to fix. “Innovation needs to deliver functionality that addresses real market needs, which is exactly what we’re working on at miDiagnostics. I believe our technology will be truly disruptive in the diagnostics field,” says Katleen.

Adaptable Workforce

Katleen expresses that working in a time-pressured environment requires the organization to be dynamic and flexible, which is crucial. She notes, “We value people’s ability to work in an agile way. We also need a team with complementary expertise who can proactively manage the interplay between many different disciplines.”

Katleen tried to lead by example to help encourage the culture with respect for team members and complete transparency. She thinks open communication lines are of utmost importance for building one team all motivated to work towards the same goals.

Cohesiveness is essential for navigating difficulties and achieving ambitions; believing that the right team makes the difference between failure and success!

Comprehensive Range of Healthcare Tools

miDiagnostics is revolutionizing diagnostics through silicon chip technology using a miniaturized nanoFluidic Processor with high-precision liquid control. It can rapidly process virtually any biomarker (including cells and genetic material). This has enabled, for example, ultrafast COVID-19 testing with the accuracy of a PCR but throughput time of a rapid antigen test (15 minute turnarounds, as opposed to the usual 3 hours for classic PCRs).

Apart from the speed, the other advantage of this technology is the miniaturization, which makes it portable and has the potential to be used at the point of care, even in a home setting.

This allows the company to develop portable diagnostic devices, enabling very accurate diagnostic testing of patients at home.

“We believe our technology has the power to be as disruptive to the traditional diagnostics industry as microprocessors were to electronics, enabling the shift from mainframe computers to portable tablets,” asserts Katleen.

Desired & Upcoming Changes

The pandemic illustrated that organizations could accelerate diagnostics development beyond its previous pace, paving the way for faster approvals from ethical committees overseeing trials and regulatory bodies approving innovations. Katleen believes that matching the momentum in indications other than COVID-19, where rapid diagnostics innovation can save millions of lives through recurrent screening of patients, ideally in the comfort of their homes.

She continues, “To stop us moving forwards with the brakes on, we also need more financial resources. The bulk of finances still flows to pharmaceutical development. We are limping behind in diagnostics, even though the pandemic has unequivocally demonstrated how essential diagnostics are for effective global health.”

Planning the next steps by witnessing the trend of decentralization with diagnostics offered on-site. In general, Diagnostics’ progress has been hindered by limitations in sampling and testing technology. The industry struggles to combine accuracy, portability, scalability, and affordability. It is miDiagnostics that has the technology to overcome these challenges.

“What we need is more disruptive technology based on truly innovative ideas. The miDiagnostics technology was initially developed by imec, a Belgian semiconductor R&D and innovation hub, in close collaboration with Johns Hopkins University, the US research, and medical center. Thanks to this unique partnership, our novel approach was developed, which is allowing our company to break through the barriers and bring miniaturized, rapid, easy-to-use, labquality tests direct to the people who need them,” explains Katleen.

Above and Beyond

Katleen aims to assist miDiagnostics blossom into a sustainable and global commercial organization with enough funding to expand the company’s IP and portfolio further. With the support of imec, Johns Hopkins, its partners, and a growing team of talented individuals, it is well positioned for a major impact in diagnostics. It is precisely what Katleen ultimately cares about: helping to shape a future with better healthcare for everyone.

Guiding Light

In her advice to aspiring entrepreneurs aspiring to venture into the diagnostic testing sector, Katleen says, “Innovative technology is important, but it is not the only factor determining company success! To make it in this field, you must understand the market and make sure you’re developing solutions to real unmet needs. You will also require both financial and human capital. You’re best-off finding investors who care about creating long-term value for the company.”

“And as for your team: make sure you build a group with complementary skills and experiences who can work together towards success. If you want to make a difference in this world, don’t work in isolation – make sure that the needs and strengths of others are always a part of the equation,” Katleen concludes.