Nexsen (ASX:NXN) expands GBS diagnostic platform into neonatal care with $500,000 AEA Ignite grant

Nexsen has secured a $500,000 non-dilutive Federal Government grant under the Australia’s Economic Accelerator Ignite program, awarded to RMIT University with Nexsen as commercialisation partner, to extend its rapid Group B Streptococcus diagnostic technology from maternal screening into neonatal testing, marking an important step in broadening the clinical scope of its point of care platform.

Highlights

• $500,000 in non-dilutive Commonwealth funding awarded under the highly competitive AEA Ignite program
• Total project value of $1,029,538, with contributions from the Commonwealth, Nexsen and RMIT University
• Customisation of Nexsen’s GBS Rapid Sensor for neonatal testing, targeting early-onset and late-onset GBS infections
• GBS Rapid Sensor for maternal screening currently in clinical trials and progressing toward a 510(k) pre submission meeting with the US Food and Drug Administration
• Expansion into a new clinical setting while preserving capital and supporting progression toward clinical validation of an additional diagnostic application

Group B Streptococcus remains a leading cause of severe infection in newborns worldwide, with an estimated 232,000 cases of invasive disease in 2020 and approximately 92,000 associated deaths and stillbirths.

Survivors are at increased risk of long-term neurodevelopmental impairment, underlining the clinical importance of rapid and accurate diagnosis at or shortly after birth.

Against this backdrop, the AEA Ignite funded project titled Transforming Neonatal Care with a Rapid Diagnostic for Group B Streptococcus aims to adapt Nexsen’s existing maternal GBS Rapid Sensor technology into a point-of-care diagnostic suitable for neonatal testing.

The project will focus initially on delivering a neonatal GBS diagnostic device with analytical and pilot clinical performance validated over the next year.

The work is being undertaken by Nexsen in collaboration with researchers at RMIT University and will also demonstrate the ability of the company’s diagnostic platform to support development of additional biomarker based tests for other clinical indications.

Selection under the AEA Ignite program highlights the relevance of Nexsen’s technology to the Australian Government’s advanced manufacturing priority and its potential for scalable clinical and commercial deployment.

From a corporate perspective, the structure of the funding provides leverage to progress development while limiting balance sheet impact.

Of the $1,029,538 total project value, the Commonwealth is contributing $500,000, Nexsen $100,000 in cash and $100,000 in kind, and RMIT University $329,538 in kind.

This supports advancement into a new clinical application while preserving capital and accelerating development timelines.

The neonatal program builds directly on Nexsen’s existing maternal GBS Rapid Sensor, which is currently undergoing clinical trials and progressing toward a 510(k) pre submission meeting with the US Food and Drug Administration.

That device is designed to address a gap in current antenatal screening practices by providing rapid point-of-care detection of GBS in pregnant women, and the AEA Ignite funding enables the same underlying technology to be customised for use in newborns.

Managing Director Mark Muzzin said the grant underpins both clinical and strategic expansion, noting that

“this funding supports an important extension of our GBS program into neonatal care, a clinical setting where rapid and accurate diagnostics can have a direct impact on outcomes, and allows us to broaden the clinical utility of our technology while advancing a larger global testing opportunity with minimal capital outlay for Nexsen.”

In parallel, Nexsen’s Chief Innovation Officer and Director of the RMIT Sir Ian Potter NanoBioSensing Facility, Distinguished Professor Vipul Bansal, highlighted the translational readiness of the platform and the strength of the long-standing collaboration between the university and the company, pointing to the ability to efficiently extend established capabilities into new clinical applications.

Looking ahead, the neonatal GBS project positions Nexsen to validate an additional use case for its point-of-care diagnostic platform while demonstrating scalability across multiple clinical settings.

With maternal GBS testing already in clinical development and regulatory engagement underway in the United States, the extension into neonatal screening situates the company within a broader global context of efforts to improve early diagnosis of serious infections in newborns, supported by non-dilutive funding and aligned with national priorities for advanced medical technologies.

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