Diagnostics developer DeepUll has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its rapid bloodstream infection test.
The UllCORE Bloodstream Infection (BSI) Test is a one-hour, multiplex, real-time polymerase chain reaction assay that extracts and analyzes total microbial DNA from 8 ml of whole blood. It can detect 95% of pathogens associated with bloodstream infections that may lead to sepsis, as well as select genetic determinants of antimicrobial resistance (AMR), DeepUll said in a statement.
Barcelona-based DeepUll focuses on developing culture-free diagnostics for rapid pathogen identification.
"We are thrilled to receive breakthrough designation from the FDA" Jordi Carrera, CEO and co-founder of DeepUll, said. "Providing life-saving results for patients suspected of serious infection in one hour represents a significant advantage over current standard of care blood culture. Faster pathogen identification and AMR testing will provide clinicians with a powerful tool to more quickly and accurately tailor antimicrobial therapy, which could lead to faster patient recovery, shorter length of stay, and reduced morbidity and mortality."
