Regulation Now Decides Which Diagnostic Test Gets Built

Not the science. Not the need. The paperwork decides first.

I spent an hour this week with Mirko Brummer, CTO of Reagena, a Finnish company that builds diagnostic tests for diseases most large manufacturers will not touch. Puumala hantavirus. Lyme disease. Markers where a positive blood sample is hard to find, and validation takes months of digging through personal networks instead of a lab freezer.

He gave me one example that explains the shift most clearly.

A university group finds a new marker against a disease. They bring it to a company. Ten years ago, a small agile company would say yes on the spot. Build a lateral flow prototype in a week or two. Put it in front of real users and learn whether it works before spending a fortune proving it on paper.

That path is closed now. Regulation now requires proof before launch, the same proof that used to happen after launch, in the field, through real use. I call it a system that has confused caution with progress.

The line between necessary evidence and unnecessary cost has been drawn in the wrong place.

Regulation does not scale down. A small company chasing a rare disease marker pays the same cost as a large company chasing a blockbuster test. Mirko compared it to two ships in the same sea. The waves are identical. The big ship rocks less. Size buys stability, and stability has nothing to do with better science.

The number he gave me was blunt. Regulatory work alone now runs past one hundred thousand euros before a company can even test whether the market wants the product. For a small diagnostics company, that cost determines whether to attempt the analyte at all.

What still works, even inside this system, is worth naming.

Reagena keeps its edge by staying close to the people who supply hard-to-find samples: professors, researchers, relationships built over years. Large companies lose this because their people rotate too often to keep it alive.

They also pick battles a small company can move fast on. Lateral flow technology is cheap to prototype and easy to scale to millions of units once it works, which keeps the regulatory bet smaller even when it is still large.

They are also testing whether artificial intelligence can absorb part of the documentation load. Mirko was clear about the discipline behind it. The tool searches hundreds of documents in seconds, not hours. A person still checks what it produces before it goes anywhere near a submission.

The cost of drawing the line in the wrong place is not abstract.

Every exploratory product that never gets tried because the upfront proof is too expensive is a test that never reaches a patient. Reagena's tests are already doing that quiet work, including a Finnish hantavirus test that turned out to also detect the Andes hantavirus in Chile, a use nobody had planned for and one regulation would make far harder to discover today.

If you run a diagnostics company, take one marker you believe in but have not pursued because the regulatory path looks too expensive to justify. Ask whether the cost in front of you protects patients or just protects the process. The answer usually tells you what that marker is already costing the people who could have used it.

The next decade in diagnostics will belong to companies that keep testing new ideas cheaply, inside a system built to make that harder. Those companies will bring more useful tests to more patients than the ones that simply have more capital to absorb the cost.

Kauko Väinämö

Kauko Väinämö is CEO of Ginolis, a precision automation company for microfluidics and diagnostics manufacturing based in Oulu, Finland, with over 150 production lines across 37 countries.