Image created by Dr. Michael J. Miller
deepull, a medical diagnostics company developing culture-free diagnostic solutions for rapid pathogen identification, announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its UllCORE Bloodstream Infection (BSI) Test.
The one hour, direct-from-blood test detects 95% of pathogens associated with bloodstream infections that may lead to sepsis, as well as select genetic determinants of antimicrobial resistance (AMR). The real-time multiplex PCR system extracts and analyzes total microbial DNA from 8 mL of whole blood, circumventing the lengthy and less sensitive blood culture process.
Jordi Carrera, Chief Executive Officer and Co-Founder of deepull, said: “We are thrilled to receive breakthrough designation from the FDA. 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.”
The FDA Breakthrough Devices Program is intended to provide patients with more timely access to innovative technologies that enable more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions by supporting manufacturers to bring them to market faster.
Melissa Finocchio, deepull’s Chief Quality & Regulatory Officer, explained: “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.”