Three European start-ups are developing automated molecular diagnostics tests that slash the time it takes to detect and treat serious gastro-intestinal and respiratory diseases for patients admitted in emergency departments and intensive care units.

When someone goes to hospital seriously ill, doctors often have to treat with antibiotics before the results of time-consuming tests come in. The consequence is that patients stay longer than necessary in hospital and are given ineffective treatments, which can also increase the chance of antibiotic-resistant disease.

With innovative tools that facilitate the preparation of samples, automatically run comprehensive tests, and analyze results, the German company Curetis, Spain’s STAT-Dx and Finnish-French Mobidiag aim to solve this problem for a range of diseases.

“Our Unyvero kit takes between four to five hours from sample to answer in a fully automated platform that takes just a few minutes of hands-on time,” says Oliver Schacht, chief executive of Curetis.

In Holzgerlingen near Stuttgart, this start-up that started with just 6 people is currently marketing four diagnostic test cartridges for four distinct serious infectious disease syndromes: pneumonia, implant and tissue infection, blood culture testing and intra-abdominal infections. “Several more cartridges are in development, for example, for urinary infections and sepsis, one of the main cause of death in patients treated in intensive care units,” he adds.

Mobidiag and Stat-Dx are supported by the European Investment Bank’s InnovFin Infectious Diseases Finance Facility, which provides a range of financial products to innovative companies developing vaccines, drugs, medical and diagnostic devices or novel research for combatting infectious diseases. Curetis was financed under the Investment Plan for Europe. Both mandates are set-up by the EIB in collaboration with the European Commission.

Mobidiag, a Finnish-French start-up headquartered in Espoo, developed a molecular test allowing simultaneous detection of the main enteric viruses causing diarrhoea.

Improving quality of care

Barcelona-based STAT-Dx proposes a platform which allows syndromic testing in about one hour, versus a minimum of 4-6 hours for other methods. “DiagCORE offers on-demand testing, which means the instrument is ready whenever and wherever one test needs to be run,” explains co-founder Jordi Carrera. “With other methods, samples are often batched before testing and laboratories might be closed when test result becomes available. This further delays the results needed to make critical clinical decisions.”

Meanwhile, Mobidiag has developed two platforms to detect gastrointestinal infections: Amplidiag is already on the market addressing large laboratories, while Novodiag – focussing on emergency settings requiring fast results should be out in December.

“Amplidiag is a great success in Nordic countries, where we have closed long-term agreements with large private and public laboratories. We are now moving into France and in the UK,” says Mobidiag chief executive Tuomas Tenkanen.

Like Curetis and STAT-Dx, diagnoses by Novodiag are very quick compared to classical methods. “Amplidiag is a platform that can run up to 48 stool samples and provide results after two hours and a half,” says Tenkanen. “For Novodiag, the time will be reduced to one hour.”

Reducing unnecessary antibiotic treatments

The tests aren’t just quick. They will also tackle a big problem highlighted by the World Health Organisation and the Centre for Disease Control and Prevention: severe antibiotic resistance. For instance, Mobidiag allows the identification of resistance to two main antibiotics, carbapenemase and colistin.

Today`s clinical gold standard microbiology culture takes several days, and sometimes weeks, to get results. That forces doctors to choose antibiotics without any diagnosis of pathogen and resistance patterns. The molecular diagnostics tests are intended to reduce unnecessary antibiotic treatments which can increase the likelihood of additional antibiotic resistance, hospital stays, prolonged illnesses, deaths, excessive medical procedures and redundant visits to the doctor. That’s because the exact cause of the disease can be treated following a clear diagnosis

Thousands of euros saved per patient

These tests are also cheaper than manual systems.

“Our test typically sells in the EUR 150 to EUR 250 range,” says Curetis’ Schacht. “A single additional day spent in an intensive care unit costs more than EUR 2,000. Innovative diagnostics have the potential to save patients’ lives, but also to cut costs for hospitals that are often facing increasing cost pressure.”
 

The Curetis Unyvero platform and its four cartridges work with respiratory samples, tissues, swabs, and synovial fluids from joints, while tests from blood and urine are currently under development. © Curetis GmbH.

All three CEOs agree that these automated kits allow improved quality and consistency, because they are not subject to human error or fatigue.

“A tired laboratory technician at 3 a.m. can run these tests just by following some simple steps that take a few minutes,” says Tenkanen.

Carrera, who hopes to launch his DiagCORE platform at the 28th European Congress of Clinical Microbiology and Infectious Diseases in Madrid next year, highlights simplicity and safety. “DiagCORE can work with most specimens without extensive offline preparation,” he says. “Our cartridge has embedded sample preparation capabilities. That simplifies and increases the security of the work of laboratory technicians and enables the platform to be directly installed in the clinical wards. They don’t need to use harmful chemicals, sharps or be unnecessarily exposed to infectious materials. It also enables less skilled people to use the system in point of care settings”.

A significant financial support

Curetis, Mobidiag and STAT-Dx all started with small teams and quickly developed, partly thanks to the backing of the EIB’s Infectious Diseases Finance Facility.

“We learnt about the EIB debt financing facilities at a BIO Deutschland workshop and then reached out to the team,” says Schacht. “From start to finish this was a smooth, transparent and very efficient process for Curetis. I have highly recommended this type of EIB funding to many of my biotech industry peers in Europe.”