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1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens

By LabMedica International staff writers
Posted on 25 Apr 2024
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Image: The real-time multiplex PCR test is set to revolutionize early sepsis detection (Photo courtesy of Shutterstock)
Image: The real-time multiplex PCR test is set to revolutionize early sepsis detection (Photo courtesy of Shutterstock)

Sepsis contributes to one in every three hospital deaths in the US, and globally, septic shock carries a mortality rate of 30-40%. Diagnosing sepsis early is challenging due to its non-specific symptoms that can be easily overlooked. Currently, the main method for sepsis testing involves complex blood culture tests that can take days to yield results. This approach, which has been standard for over 40 years, is only able to detect 'viable' organisms, thus missing a broader range of potential microbial analytes present in the blood. Now, a groundbreaking diagnostic system currently under development could revolutionize life-saving clinical decision-making for sepsis patients.

Deepull (Barcelona, Spain) has unveiled its UllCORE benchtop diagnostic system that is capable of delivering 50 reportable results within an hour. This system covers 95% of pathogens known to cause sepsis, including resistance genes. The real-time multiplex PCR system operates by extracting total microbial DNA from an 8 mL sample of whole blood, bypassing the traditional and time-consuming blood culture process. The UllCORE assay encompasses a broad array of bacterial targets, fungi, and genes that create antibiotic resistance, enhancing the ability of clinicians to make more informed decisions faster. This rapid and sensitive technology aims to reduce the risks associated with inappropriate antibiotic use, thereby aiding in the battle against antimicrobial resistance in hospital settings.

Preliminary results of the assay based on prospectively obtained specimens from patients with sepsis have shown high agreement with positive blood culture results. Remarkably, it has also been able to identify over twice the number of clinically relevant pathogens as compared to traditional blood cultures. While the focus is currently on sepsis, Deepull envisions broad applications for the UllCORE system in diagnosing a variety of acute infections. Deepull is actively seeking to build strong partnerships with hospitals and laboratories as it prepares to launch clinical trials in 2025.

“Introducing the UllCORE platform and its unique capabilities to the market is a significant milestone for deepull,” said Jordi Carrera, Chief Executive Officer and Co-Founder of deepull. “We are encouraged by early results based on prospectively obtained specimens from septic patients and look forward to initiating clinical trials next year, as well as refining the platform ahead of commercial launch. We believe our UllCORE system could transform the standard of care for sepsis diagnosis, for the benefit of patients globally.”

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