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Curetis AG: Miniaturised laboratory for the simple, rapid and reliable diagnosis of serious infections

Pneumonia affects around 800,000 people in Germany every year and results in about 20,000 deaths. It is therefore a leading cause of death from infection in Germany. Acute pneumonia usually leaves doctors with no choice; the situation can quickly become life threatening, requiring doctors to act quickly. Instead of waiting for laboratory results, they often prescribe an antibiotic that is effective against numerous bacterial species in the hope that it will also work against the bacterium that has caused the inflammation in the lung tissue. Curetis AG from Holzgerlingen close to Stuttgart has developed a miniature laboratory that facilitates and hugely accelerates the diagnosis of pneumonia pathogens.

Cartridge-sized laboratory for the diagnosis of pneumonia. © Curetis AG

“The sooner a doctor can obtain information about pathogens and antibiotic resistances the better. A lead of just a few hours can even save the life of a patient with acute pneumonia,” said Oliver Schacht, CEO of Curetis. “Our system provides hospitals and doctors with diagnostic information completely automatically within a few hours. Current diagnostic procedures rely on culture-based technologies that can take days to deliver results. A patient sample, for example secretions that are removed by suction, is all that is needed. Curetis’ Unyvero™ system is a versatile hardware platform that enables the identification of a broad range of pathogens and antibiotic resistances in a single test panel from a small patient sample.

The disposable Unyvero™ cartridges integrate all sample analysis steps and execute a complete test from sample purification to final result. “Our miniature laboratory helps save time and money,” said Oliver Schacht going on to add that “rapid diagnosis enables the early and specific treatment of the disease and also speeds up recovery time.”

Groundbreaking molecular diagnostics of infectious diseases

The Unyvero™ system enables the DNA-based testing of any clinically relevant sample in a fully automated analysis process, requiring only a few, quick manual preparation steps. The analysis of the samples can therefore be carried out with minimal operator time and without the need for specifically trained personnel or a special infrastructure, which also saves on costs.

Combination of molecular biology know-how

Curetis’ management team has long-standing experience in the fields of molecular diagnostics and medical technology. Johannes Bacher, COO of Curetis, comments: “Curetis is well positioned to address the global in vitro diagnostics market. The expertise of our team covers all steps from the identification of clinically relevant applications to product design specifications, development, design and the manufacture, marketing and commercialisation of products.”

To date, Curetis has raised equity capital of 49.1 million euros from leading European venture capital companies. The company has also signed several strategic R&D partnerships and commercial agreements, including with Sanofi Pasteur, Heraeus Medical and Cempra Pharmaceuticals. It has also signed distribution partnerships for the Benelux countries, Russia (as well as some former CIS states), the Middle East, Turkey, former Yugoslavia and Romania.

Strong growth – IPO cannot be ruled out

A pipeline of application-specific cartridges. © Curetis AG

Curetis will use the funds it has raised for the next phase of operational and commercial growth. This includes a prospective, multicentre clinical trial with more than 2,000 patients aimed at achieving clearance from the American FDA and expanding commercial activities and the commercial team in Europe. Curetis anticipates a phase of rapid market adoption in the so-called DACH region (Germany, Austria, Switzerland) where more than 50 top tier hospitals have agreed to install Unyvero for local testing. In addition, the company anticipates the further expansion of its distribution system in European countries, the Middle East, Asia, Latin America and, after FDA clearance, also in the USA. “In order to further finance our success, we do not rule out a national or international IPO in the USA,” said Oliver Schacht with a certain degree of optimism. 

Clear focus on infectious disease diagnostics

In the Western world, more than 25 million people are diagnosed with bacterial infections every year, which is a significant burden on healthcare systems. In addition, antibiotics-resistant bacteria are a growing threat in hospitals and nursing homes. The early identification of pathogens therefore plays an important role in mitigating this problem. “There remains a need for technologies that enable the acquisition of accurate and comprehensive diagnostic information in order to make rapid and appropriate decisions on antibiotic treatment,” Schacht explained.

Cartridges for other diseases, including infections of the central nervous system and the digestive tract, sepsis and tuberculosis are in the production pipeline. “Curetis has decided to remain in the field of infectious disease diagnostics on the basis that we feel that the company should stick to what it does best,” said Schacht talking about the company’s strategic orientation.

Another milestone in sight

Cartridge manufacture in the clean room. © Curetis AG

Curetis is currently focussed on the launch of the second Unyvero™ cartridge (post-operative and implant-associated infections – ITI) that was developed in close cooperation with Heraeus Medical. The new cartridge covers a broad range of infections that are common after surgical interventions, traumas (e.g. burns), infections that affect skin and soft tissue (including diabetic foot) and implant infections. 

“We are very pleased to be able to contribute to an individual treatment plan for joint implants that is based on conclusive diagnostic results,” said Dr. André Kobelt, CEO of Heraeus Medical GmbH. “This approach provides cost bearers with greater economic efficiency, orthopaedic surgeons with clarity and is associated with less stress for patients – in short, the approach is a boon for all concerned. The new cartridge is a cutting-edge technology that enables clinicians to identify bacteria and antibiotic resistances rapidly.” 

Following successful assay development, Curetis is currently carrying out validation and verification studies and is preparing a clinical evaluation to assess the performance characteristics of the i60 cartridge with a view to CE marking. The company aims to achieve CE marking of the Unyvero™ i60 cartridge by the end of March 2014. 

Further information:

Dr. Oliver Schacht
Curetis AG
Max-Eyth-Straße 42
D-71088 Holzgerlingen

Tel: +49 (0) 7031 49195-12
Fax: +49 (0) 7031 49195-19

E-mail: oliver.schacht(at)curetis.com

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/curetis-ag-miniaturised-laboratory-for-the-simple-rapid-and-reliable-diagnosis-of-serious-infections