Curetis attaches great importance to validating its products according to international standards. Studies are currently underway in the USA and Europe and additional studies are being prepared to evaluate the medical and economic benefits of rapid multiplex PCR tests on infectious disease following market introduction.

You can find publications on the various studies here.

The following studies are currently underway:

Unyvero Pneumonia Application 

  • FDA 510(k) Application : Prospective, multicentre study with over 2,200 patient samples has been completed and results have been submitted to the FDA for clearance
  • CFDA clearance for commercialisation in mainland China
  • FLAGSHIP: Fast Multiplex Assay of Gram negative rods for antibiotic Stewardship in Hospitalized Patients
  • Prospective, block-randomised, controlled, multicentre intervention study in Switzerland.
  • INHALE: Potential of molecular diagnostics for hospital-acquired and ventilator-associated pneumonia in UK critical care
  • Evaluation Studies from Hospitals in Belgium, France, Germany, Greece, Italy, Netherlands, Spain and UK

Unyvero ITI Application

  • Prospective, controlled, intervention study of a rapid bacterial multiplex PCR as point of care in the management of acute presentation of native joint infection. Northumbria, UK
  • Performance of Unyvero ITI in the diagnosis and management of Diabetic foot infection. Nimes, France
  • Evaluation Studies of Hospital Customers in Austria, Denmark, France, Germany, Netherlands, Norway, Switzerland and UK

Completed Studies:

The Curetis GmbH has successfully concluded 30 studies with Unyvero, including data from over 4,000 tested patient samples.

Unyvero Pneumonia Application

  • CE performance evaluation study with 392 patient samples
  • Prospective multicenter EU study with 822 patient samples
  • Clinical evaluations (e.g. in Munich, Basel, Kuwait, Chicago and Maastricht)
  • Research-based studies in pediatrics in Germany, Austria and Switzerland

Unyvero ITI Application

  • CE performance evaluation study with 339 patient samples
  • Clinical evaluation (for example Madrid, Freiburg, Bonn, Nantes)