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HMD-301 for diagnosis of Urinary Tract Infection: novel clinical results published

Regulatory information
Hansa Medical’s clinical research partners at Skåne University Hospital in Lund have conducted a clinical study demonstrating that the patented diagnostic method HMD-301 is suitable for diagnosis of Urinary Tract Infections in children. The results of the study have been published online by the scientific journal Pediatric Nephrology

Urinary tract infection (UTI) is a common infection diagnosis in children, and efficient diagnosis and treatment is important to avoid serious complications. The published study shows that by quantifying the level of Heparin Binding Protein in urine samples, individuals with UTI could be discerned with sensitivity above 90 % and specificity above 90%. These levels of accuracy are highly competitive in comparison with the commonly used methods for UTI-diagnosis today: Nitrite quantification, White Blood Cell count or Interleukin-6 quantification. The study involved a small group of patients (78 children aged 0-18 years) and further studies are ongoing with a larger group of patients.

”The results from the published study are very promising and make up an additional development opportunity for the patented diagnostic method HMD-301", says Emanuel Björne, CEO of Hansa Medical AB

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