Curetis is the first company to receive FDA approval to market a molecular diagnostic test for lung infections in the US. The test reduces the time taken to reach a diagnosis from several days under five hours.

The FDA has given Curetis, a German biotech, the green light to launch its first-in-class Unyvero platform for diagnosing lung infections in the US. This is the first of the biotech’s line of rapid cartridge diagnostic tools to receive market approval in the US, and the company plans to develop its device for diagnosing other conditions as well.

The Unyvero platform uses cartridges to identify multiple molecular markers for disease. Tracheal aspirate samples are loaded onto the cartridge. The device is then able to detect more than 30 bacterial species known to cause lower respiratory infections and identify 10 genetic markers for antibiotic resistance using PCR and array hybridization.

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“In hospitals, it takes two, sometimes three days or more to identify the pathogens and the antibiotic resistance that are potentially killing patients in hospitals every day,” Oliver Schacht, CEO of Curetis explained to Philip in an interview. Unlike the current diagnostic standard, which consists in culturing the bacteria in a lab over several days, Curetis’ cartridge yields results in less than five hours.

Furthermore, the Unyvero platform detects over 90% of infections in hospitalized patients with pneumonia and provides a comprehensive overview on a patient’s genetic markers for antibiotic resistance. Overall, this allows effective treatments to reach patients sooner, reducing their recovery time and benefiting hospital finances.

First Rapid Molecular Diagnostics Test for Lung Infections Approved in the US

Curetis’ cartridge technology can be used to diagnose lung infections.

Moreover, the Curetis’ cartridge system could mark an important step forward in combating antimicrobial resistance. Antimicrobial resistance poses an immense threat to healthcare systems worldwide, currently leading to around 700,000 deaths per year. Antimicrobial resistance is spread in part by the misuse of antibiotics.

“We need to get to a point where we make rational decisions about using antibiotics. The good news is the drugs are all there, we just gotta be able to pick the right ones based on a diagnostic result and get the right treatment to the right patient,” elaborated Schacht.

Curetis’ leading position is in developing treatments that combat antimicrobial resistance has drawn the interest of investors. The biotech was the only German company to launch an IPO in 2015, which raised €40M. Today’s news has reinforced the confidence of investors in Curetis’s technology, with stock prices this morning rising by nearly 15% since closing time on Tuesday.

Nonetheless, it’s been a long road to get the FDA’s approval for the Unyvero platform for diagnosing lung infections — the company launched its cartridge for the same indication in Europe in 2012.


Images by Curetis, Kateryna Kon/Shutterstock

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