Fredrik Wernstedt, CEO of Direkttest, explains how the UAE contact emerged through a French laboratory partner.
“The United Arab Emirates wants to explore what opportunities we can offer. They are looking at three wellness-oriented test panels, with an estimated annual volume of around 20,000 samples. Dubai is the first area of focus, and then we will expand from there.”
Regulatory steps and the challenge of heat
To enter the region, Direkttest must register with the country’s equivalent of a medical products agency. Their existing European approval is an advantage, but practical hurdles remain.
“They operate within a different temperature range. Our products are qualified from –20°C to +50°C, but some other aspects are still being evaluated,” says Wernstedt.
Despite this, the company sees substantial opportunities ahead.
“It would of course be exciting to enter a new market—especially one with strong willingness to pay in certain segments.”
Growing quietly after the pandemic
Direkttest Sverige AB was founded in 2020 at the height of the global pandemic. The company develops digital tools for diagnostics and research, and the urgent national need for large‑scale testing accelerated its early growth. Direkttest emerged from Karlsson & Novak, and the pace was intense.
“It was incredibly busy, and remarkable to see how every stakeholder worked together to curb the spread of infection. We’ve never seen ideas, decisions and implementation move so quickly.”
Together with Umeå University and the UBI alumni Xerum, Direkttest delivered antibody tests for the Public Health Agency’s monitoring program for elderly residents in care facilities. During the pandemic, the company handled 6 million samples, transforming perceptions of self-sampling within Swedish healthcare.
“Both healthcare providers and patients came to recognize the benefits. Capillary blood sampling is now the fastest‑growing method, both in research and clinical practice.”
Major savings but slow adoption in the healthcare system
The rapid development of capillary sampling enables significant cost reductions.
“We are entering projects where budgets can be cut by up to 75 percent thanks to self-sampling and the shift from venous to capillary samples. That wasn’t possible a few years ago.”
Yet navigating the healthcare system is anything but straightforward.
“We often find that providers and researchers simply don’t know that this alternative exists. We actually wish there were more competitors to raise awareness.”
“We see huge potential to help patients with chronic conditions, such as thyroid issues, type 2 diabetes, or cardiovascular disease, avoid unnecessary trips to the clinic. But local health centers are often uninterested. Labs say there is no need, while health centers benefit from the patient fees that come with in‑clinic testing.”
International collaborations from Norway to Oxford
Despite the challenges, Direkttest has secured a strong foothold across several domains:
- Capio, one of Sweden’s major private care providers, is a customer.
- The Public Health Agency and Umeå University use Direkttest for vaccine surveillance.
- The University of Oxford is running a large research study in which Direkttest distributes sampling kits to psoriatic arthritis patients across twelve European countries.
- In Norway, the company oversees medication‑monitoring programs for kidney transplant patients.
“When transplant patients receive immunosuppressive medication, they need to be sampled four times within a few hours. Now they can do it at home instead of spending an entire day at the hospital,” Wernstedt explains.
100,000 samples in new Swedish flagship project
One of the company’s largest assignments to date is a major procurement recently won in Uppsala.
“This research project aims to gather 100,000 samples per year over ten years. Participants between 55 and 75 years old will provide yearly samples, which will be stored in a biobank. Researchers are looking for biomarkers linked to the five most common cancer types.”
Eight employees
Direkttest remains a small company, with eight employees across the group, but anticipates moderate and continued growth. Its strength lies in its fully integrated offering: handling everything from invitations and digital consent to referrals, test results, survey management, and the assembly and distribution of sampling kits.
“The key to growth is finding the right people within the regional healthcare systems, and raising awareness of the value that self-sampling brings to healthcare, society and patients alike.”
FACTS – Direkttest Sverige AB
Founded: 2020 (Since 2021, Direkttest Sverige AB and Karlsson & Novak Medical AB have operated under the joint group Vimila AB.)
Headquarters: Umeå
Employees: 8
What they do: Self‑sampling services, assembly and distribution of sampling kits, test results for both providers and individuals, survey administration, and customer support.
History: The digital platform enabling secure information flows between laboratories, individuals, and patient records originated from a home‑testing service for chlamydia developed in 2005 by Karlsson & Novak. It has been used by Swedish regions ever since. In spring 2020, the platform was rapidly expanded (together with the Västra Götalands Region) to meet the urgent need for large‑scale COVID‑19 testing, leading to the formation of Direkttest Sverige AB.