Deepull's UllCORE Bloodstream Infection Test Receives FDA Breakthrough Device Designation
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Deepull (search)'s UllCORE BSI test (search), which delivers results in one hour, has received FDA Breakthrough Device Designation, expediting its development and review process.
The test identifies 95% of pathogens associated with bloodstream infections and detects antimicrobial resistance (search) markers directly from blood samples.
UllCORE BSI test (search) utilizes real-time multiplex PCR to analyze microbial DNA from whole blood, bypassing the limitations of traditional blood culture methods.
Deepull (search), a medical diagnostics company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its UllCORE Bloodstream Infection (search) (BSI) Test. This designation is intended to expedite the development and review of innovative technologies that can provide more effective treatment or diagnosis of life-threatening conditions.
The UllCORE BSI Test (search) is designed to identify 95% of pathogens associated with bloodstream infections, which can lead to sepsis (search), and also detects select genetic determinants of antimicrobial resistance (search) (AMR). The test delivers results in one hour directly from blood samples, offering a significant advantage over traditional blood culture methods, which can take days to yield results and may miss critical pathogens.
The test employs a real-time multiplex PCR system to extract and analyze total microbial DNA from 8 mL of whole blood. This approach bypasses the lengthy and less sensitive blood culture process, potentially enabling clinicians to tailor antimicrobial therapy more quickly and accurately.
"We are thrilled to receive breakthrough designation from the FDA," said Jordi Carrera, Chief Executive Officer and Co-Founder of deepull (search). "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."
Preliminary results from the UllCORE BSI Test (search) have demonstrated high concordance with positive blood culture results and have detected over twice as many clinically relevant pathogens compared to traditional methods. The test includes 52 reportable results and operates on the deepull (search) UllCORE analyzer, a benchtop system designed for hospital clinical laboratories.
Melissa Finocchio, deepull (search)’s Chief Quality & Regulatory Officer, emphasized the importance of early diagnosis in treating infections, particularly sepsis (search). "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."