Taking the Next Biggest Leap in our Research

Bellberry Human Research Ethics Committee (HREC) has just granted approval for our ENBOARD clinical study.

That's right - we are tackling one of our biggest challenges yet.

The ENBOARD study is no mean feat - we aim to establish new correlations between nasal molecular biomarkers with chronic respiratory patient disease severity. ENBOARD (Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders) will dive into conditions ranging from asthma, chronic rhinosinusitis to COPD.

This is why the ethics approval milestone is crucial - we officially have the green light to tackle this immense challenge, taking on one of the most comprehensive nasal biomarker studies conducted to date.

Yet that's not the whole story (and trust me it gets even better).

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Validating a diagnostic tool with the potential to change respiratory research

Alongside biomarker investigations, ENBOARD will also validate the tolerability and performance of the ABEL nasal microsampler.

This device, designed by our dedicated engineers Jonathan Limpah and Brian Occhipinti, is a less invasive alternative to existing diagnostic tools for respiratory disease. It allows for the collection of high-quality nasal fluid samples for biomarker analysis, with greater capacity for repetition in both clinical settings and research studies (without the need for surgical biopsies and alternative devices that might cost an arm, a leg and even a nose).

Not to mention that ABEL might open doors to at-home self-sampling. The possibilities are endless.

Why This Matters in the World of Respiratory Disease

Respiratory diseases remain a significant global health burden, and yet existing diagnostic tools continue to rely heavily on subjective measures and invasive procedures. ENBOARD seeks to:

- Advance biomarker-driven precision medicine by identifying objective molecular signatures linked to disease severity.

- Enhance patient outcomes by supporting early intervention and more effective treatment strategies.

- Validate novel sampling technologies like ABEL to improve accessibility and ease of respiratory diagnostics.

With Bellberry’s approval, we can now proceed with rigorous clinical validation, bringing us one step closer to integrating nasal biomarkers into routine clinical practice.

What’s Next?

Ultimately, we are set to launch recruitment at our clinical sites, bringing us closer to transforming respiratory disease monitoring through biomarker-driven insights.

Next, we will initiate participant recruitment at our clinical site, conduct first-in-human studies using the ABEL microsampler, and begin analyzing biomarker data to establish correlations with disease activity and treatment response.

These findings will support regulatory and commercial pathways for biomarker-based diagnostics, with preliminary results contributing to scientific publications and further validation efforts.

Follow us on LinkedIn for real-time updates on ENBOARD, insights into our biomarker research, and opportunities to get involved in shaping the future of precision respiratory medicine!

Learn more about the study on the ClinicalTrials.gov entry

About Diag-Nose.io

Diag-Nose.io, founded in 2020, is a TechBio company focused on translating the complexities of the unified airway into precision diagnostic and drug discovery solutions.

Their precision medicine technology combines advanced proteomics, computational biology, and AI (machine learning) to create a scalable respiratory biology model. This innovation aims to help clinicians prescribe the right treatments faster and enable researchers to accelerate the development of new therapies.

The company’s flagship platform, RhinoMAP™, leverages proteomic data to predict respiratory disease activity, monitor therapy response and predict treatment efficacy in advance, with an initial focus on anti-Th2 biologics.

Learn more at Diag-Nose.io

About Bellberry Limited

Established in 2004, Bellberry Limited is a national, private not-for-profit organization dedicated to enhancing the welfare of research participants and improving the quality and efficiency of human research across Australia. Bellberry provides streamlined scientific and ethical review of human research projects through its 12 Human Research Ethics Committees (HRECs), which collectively conduct up to 13 meetings monthly. These committees are certified to review a wide range of studies, including clinical drug trials, social science research, and observational studies. Operating independently, Bellberry ensures that all research involving humans adheres to the highest ethical standards and academic integrity. As a profit-for-purpose company, any surplus funds generated are reinvested into the Australian medical research community, further supporting the advancement of health and medical research nationwide.

Learn more at Bellberry's official website.