The US Food and Drug Administration (FDA) has granted breakthrough device designation to deepull’s UllCORE bloodstream infection (BSI) test.
The test, which provides results in one hour directly from blood, identifies 95% of pathogens related to bloodstream infections and certain genetic markers of antimicrobial resistance (AMR).
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It is a real-time multiplex PCR system that analyses and extracts microbial deoxyribose nucleic acid (DNA) directly from 8ml of whole blood, bypassing traditional blood culture methods, which are often time-consuming and less sensitive.
Preliminary results from the UllCORE BSI Test have shown high concordance with positive blood culture results. Notably, it has detected over twice as many clinically relevant pathogens against traditional blood culture methods.
deepull CEO and co-founder Jordi Carrera 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.”
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By GlobalDataThe FDA’s ‘Breakthrough Devices Program’ aims to provide patients with quicker access to advanced medical technologies.
Designed to target a significant proportion of sepsis-causing pathogens, the test includes 52 reportable results and operates on the company’s UllCORE analyser, a benchtop device that automates the process from sample to result, suitable for any hospital clinical laboratory.
deepull chief quality and regulatory officer Melissa Finocchio said: “Early diagnosis is critical in the treatment of a multitude of infections but most notably for sepsis where standard blood culture testing takes days to deliver and often misses critical pathogens.
“This designation facilitates early feedback and interactive discussions between deepull and the FDA, allowing us to streamline our development and submission process.”
