Unique Molecular Diagnostic Test Uses World’s First Digital PCR POC Analyzer for Detecting LRTIs

Lower respiratory tract infections (LRTIs) rank as the fourth deadliest disease globally, leading to over 2.5 million deaths every year. A significant challenge is the lack of effective diagnostic methods for these infections. Scientists are now focusing on developing a one-time-use breath collection device and a high-throughput diagnostic assay that can identify multiple pathogens at the point of need. This new approach will allow healthcare providers to distinguish between viral and bacterial infections in just half an hour after obtaining a breath sample from the patient. This solution will be the first of its kind breath-based system in the world to enable quick, precise, and targeted diagnosis of LRTIs.

Three companies—Avelo (Schlieren, Switzerland), VIVOLTA (Waalre, Netherlands), and BLINK (Jena, Germany) —are collaborating in the BreathCounts consortium. They are working to develop this ground-breaking, non-invasive LRTI diagnosis system using breath samples. Over a two-year period, they intend to create a disposable breath collection device featuring an electrospun filter and a high-throughput diagnostic assay that can screen for various pathogens at the point of need. The system is scheduled for market launch in 2027. Given the growing concern over increasing antibiotic resistance due to the incorrect use of antibiotics, having a quick and accurate diagnostic method is crucial for appropriate treatment.

This revolutionary solution will be the world’s first breath-based system for the fast, accurate, and specific diagnosis of LRTIs and will be easy to use to encourage its global adoption. Medical professionals using it will not only be able to distinguish between bacterial and viral infections but also identify the specific causative agents and any drug resistance, thus guiding optimal treatment. The diagnostic solution consists of two complementary products: AveloCollect, a new breath sampling device, and Respirex, a unique molecular diagnostic test. Current methods for collecting samples for LRTI diagnosis are either missing the target, hard to get, or highly invasive, leaving many patients undiagnosed. AveloCollect aims to change this by capturing infection-causing pathogens from the patient's breath in a quick, non-invasive way.

The AveloCollect device will also feature a highly effective filter material produced using a specific method known as electrospinning. VIVOLTA, an industry leader in medical electrospinning, will handle the optimization and scaling of this manufacturing process through its exclusive MediSpin platform. On the other hand, Respirex, designed by BLINK, is a comprehensive LRTI test that can swiftly identify multiple pathogens using just one breath sample from AveloCollect. This test, which identifies specific DNA/RNA sequences of pathogens, is based on BLINK's unique digital PCR technology. It allows for highly precise and wide-ranging molecular analysis using nanoreactor bead technology, allowing for dozens to hundreds of tests from a single sample. Respirex will be available in cartridge form, containing all the required reagents, reducing both time and variability compared to systems requiring separate reagent additions. Once the breath sample is added to the Respirex cartridge, it can be quickly analyzed in BLINK's pioneering point-of-care analyzer, the BLINK ONE.

“We are thrilled about this opportunity,” said Melanie Aregger, co-founder and CEO of Avelo. “Joining forces with VIVOLTA and BLINK will help us to develop and validate our AveloCollect breath sampling kit, which has the potential to revolutionize the field of respiratory medicine. This consortium is highly synergistic, and its expertise will greatly support our journey towards improving the diagnosis of LRTIs and clinical outcomes, as well as combating antimicrobial resistance.”

“Joining the BreathCounts consortium is a great opportunity for VIVOLTA and we are delighted to help bring this exciting diagnostic solution to the millions of patients worldwide who need it,” added Ramon Solberg, CTO and CEO ad interim of VIVOLTA. “We particularly look forward to demonstrating the full potential of our MediSpin platform, the world’s first and only fully automated medical electrospinning manufacturing system, for the mass-production of the AveloCollect device’s filter. Together with Avelo and BLINK, we believe this is a winning product coupled with a winning team.”

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