Breath sampling device shown to have 100% effectiveness

New research shows 100% effectiveness of a breath sampling device developed by Northumbria University medtech spinout, PulmoBioMed, that could aid diagnosis of several diseases, including COVID-19. 

The results mean that PulmoBioMed’s device, PBM-HALE, can be used to study infections of the deep lung, reducing the need for invasive or costly procedures often required for disease diagnosis.

PBM-Hale is a hand-held aerosol collecting device that allows sampling of the lung in a non-invasive way - by patients simply breathing into it.

To date, all inventions used for collecting breath samples are challenged by issues relating to contamination, sample loss and variability. PBM-Hale technology aims to resolve these issues, with data showing that the device detected 100% of COVID-19 cases tested in the company’s latest clinical study.

Dr Sterghios Moschos, associate professor at Northumbria University and founder and chief scientific officer of PulmoBioMed, said: “We and others have now shown with various devices that exhaled breath contains the virus that causes COVID-19. Previous studies though could not distinguish between what is coming out of the mouth (saliva) and what comes out in fine aerosol particles. Some of them were also very easy to contaminate with virus in the atmosphere or the skin. 

“Our study is the first to show that the virus can be detected in the fine aerosol particles generated in the lung, even in resting breath. It shows the virus is found mostly in the tiniest particles we breathe out, not the saliva that might be accidentally spit out as we breathe or speak. 

“This means that using our device in combination with the standard PCR test used worldwide, we can detect the genome of the virus in 100% of patients, when sampling the breath for just one minute. This would identify anyone infectious or shedding virus.

“We are also the first to show that the amount of virus produced is 90 times higher on average if you sing loudly. It reinforces why high-quality masks are important to prevent transmission indoors, and why ventilating enclosed spaces is critical to preventing transmission. These small particles are known to linger for hours if the space is not ventilated.

“The study shows that PBM-HALE can be used to study infections of the deep lung with no need for invasive procedures that present high risk to the patient and cost thousands to healthcare systems - all in a simple, hand-held device.” 

Findings from the study come as the company announces the appointment of clinical respiratory scientist Professor Peter J Barnes FRS, FMedSci as its new clinical non-executive director. Professor Barnes has published over 1,000 peer-reviewed papers on asthma, COPD and other airways disease and serves on the editorial boards of over 30 academic journals.

Speaking about PulmoBioMed’s technology, Professor Barnes said: “I am very impressed by the capabilities of the new PBM-HALE device, which is able to detect the virus that causes COVID-19 in the breath for the first time. This device has enormous potential application in diagnosing lung infections and in the diagnosing and monitoring of lung diseases, including asthma and COPD. The ease of collecting breath samples non-invasively means that it can be applied to children and to frail and ill patients.”

The process of taking academic technology to create PulmoBioMed was made possible by support from Northern Accelerator, a collaboration between Northumbria, Durham, Newcastle and Sunderland Universities to commercialise research and boost the region’s economy. 

Northern Accelerator’s ‘Proof-of-Concept’ funding supported the development of the first functional prototype. Northumbria graduate, Saqib Ali, was appointed as a design engineer at PulmoBioMed and carried out the rapid prototyping of PBM-HALE using 3D printers within the University’s engineering labs.

A second Northern Accelerator initiative, ‘Executives into Business’, supported the onboarding of the executive team, and a third programme of support, ‘Future Founders’, provided business training. 

PulmoBioMed also benefitted from North by Northwest Partner’s ‘Innovation to the Commercialisation of University Research’ (ICURe) programme, which helped validate the market for the spinout’s technology. The company won additional funding from Innovate UK to support the first 18 months of business development activities.