deepull's Innovative Blood Test Gains FDA Breakthrough Status

deepull Achieves Significant Milestone with FDA Designation

deepull has made headlines with its recent announcement regarding the UllCORE Bloodstream Infection (BSI) Test, which has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This advanced diagnostic tool is designed to provide rapid and accurate results, which is a game changer in the field of medical diagnostics.

The Power of the UllCORE Test

The UllCORE BSI test is a remarkable innovation that can detect 95% of pathogens linked to bloodstream infections that can potentially lead to sepsis. One of the standout features of this test is its ability to deliver results in just one hour, utilizing a direct-from-blood approach. This contrasts sharply with traditional blood culture methods, which can take days to yield results, thereby delaying diagnosis and treatment.

How the Test Works

This cutting-edge technology employs a real-time multiplex PCR system that extracts and analyzes total microbial DNA from only 8 mL of whole blood. By bypassing the conventional blood culture process, deepull has significantly reduced the time and sensitivity issues associated with older diagnostic techniques, making it a vital tool in urgent care settings.

Insights from Leadership

Jordi Carrera, the Chief Executive Officer and Co-Founder of deepull, shared his enthusiasm about this development, stating, "We are thrilled to receive breakthrough designation from the FDA. Providing life-saving results for patients suspected of serious infection in one hour is a substantial improvement over the current standard of care. This fast identification of pathogens, alongside the testing for antimicrobial resistance, provides clinicians with an essential tool to enhance patient care."

The Importance of Fast Diagnosis

Understanding the critical nature of early diagnosis, especially in sepsis, is a key driver for deepull's innovation. Typical blood culture tests can fail to deliver timely results, often missing crucial pathogens. Melissa Finocchio, Chief Quality & Regulatory Officer of deepull, elaborates that this designation from the FDA fosters early feedback and interactive discussions, ultimately facilitating a more streamlined development and submission process for innovative healthcare solutions.

About deepull

Founded in 2020, deepull specializes in creating culture-free diagnostic solutions that specifically target sepsis and other acute infections. Backed by a team of seasoned professionals previously involved in the successful development of diagnostic technologies, including the founders of STAT-Dx, which was sold to QIAGEN, deepull is well-equipped to introduce pioneering medical technologies to the market.

The UllCORE Analyzer

The UllCORE BSI Test runs on deepull's UllCORE analyzer, a cutting-edge benchtop system designed for sample-to-result automation. This innovative instrument is tailored to meet the needs of hospital clinical laboratories, ensuring rapid, reliable, and comprehensive testing.

Stay Informed on deepull's Progress

To keep up with deepull's advancements and learn more about its innovative testing solutions, visit their website or follow them on LinkedIn. The company is continually working towards harnessing the latest technologies to enhance the efficiency and effectiveness of patient diagnostics.

Frequently Asked Questions

What is the UllCORE Bloodstream Infection Test?

The UllCORE Bloodstream Infection Test is a rapid diagnostic tool that detects pathogens linked to bloodstream infections and provides results within an hour.

How does the UllCORE Test improve patient care?

This test enables clinicians to quickly identify infections and tailor antimicrobial therapy more effectively, leading to improved patient outcomes.

What FDA designation has deepull received?

deepull has received Breakthrough Device Designation from the FDA for its UllCORE Bloodstream Infection Test.

Why is early diagnosis crucial in infections?

Early diagnosis is essential in treating infections, especially sepsis, as timely interventions can significantly reduce morbidity and mortality rates.

What technology underpins the UllCORE Test?

The UllCORE Test uses real-time multiplex PCR technology to analyze microbial DNA extracted from blood samples, facilitating rapid and accurate pathogen detection.

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