Nexsen Limited (ASX:NXN) advancing US regulatory pathway for point-of-care diagnostics - Old_Posts

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Nexsen Limited has moved to accelerate its entry into the United States healthcare market by appointing MCRA, a specialist clinical research and regulatory advisory firm, to guide preparations for US Food and Drug Administration engagement for the company’s diagnostic pipeline.

The appointment is directed toward establishing a clear and efficient route to market for Nexsen’s lead GBS Rapid Sensor and its Kidney Function Diagnostics suite, both of which target large and clinically significant patient populations.

Highlights

• MCRA appointed to advise on US FDA regulatory strategy for Nexsen’s diagnostic portfolio
• First FDA engagement planned for early 2026 for the GBS Rapid Sensor
• GBS Rapid Sensor addresses the need for rapid testing during labour across 132 million births per year globally
• Kidney Function Diagnostics target Chronic Kidney Disease affecting ~700 million people and Acute Kidney Injury affecting ~7 per cent of hospital admissions
• Commercial-readiness activities underway with potential early international sales in the second half of 2026

Nexsen is developing a point-of-care diagnostics platform based on nano-biotechnology designed to provide rapid, low-cost testing with laboratory-comparable accuracy.

The company’s lead product, the GBS Rapid Sensor, is intended for use in expectant mothers at the time of labour, allowing clinicians to identify Group B Streptococcus in minutes.

Current standard testing often relies on laboratory processing that can take days, presenting timing challenges in acute maternity settings, particularly given the scale of need with 132 million births per year globally and an estimated one in five mothers carrying the GBS bacterium.

Clinical data generation for the GBS Rapid Sensor is currently underway under the leadership of Professor Lisa Hui, a well-regarded authority in maternal-fetal medicine.

These data are intended to support FDA submissions and international regulatory filings.

In parallel, Nexsen is pursuing commercial-readiness planning, evaluating pathways for select early international sales ahead of full US regulatory clearance, with a view to introducing the GBS Rapid Sensor to market in the second half of 2026.

The company is also progressing its Kidney Function Diagnostics suite, which spans acute and chronic use cases.

Chronic Kidney Disease affects around 700 million people globally, while Acute Kidney Injury is present in approximately 7 per cent of all hospital admissions and close to 30 per cent of admissions to intensive care units.

The ability to assess kidney status rapidly at the point of care has potential implications for treatment decisions across hospital, emergency and at-home care environments.

Nexsen Managing Director Mark Muzzin said the appointment of MCRA represents a purposeful step in shaping the company’s regulatory trajectory:

“The appointment of MCRA is a strategic accelerator for Nexsen as we advance towards US regulatory clearance and commercial entry. Their proven track record across FDA submissions and market access for breakthrough diagnostics will be instrumental as we drive the GBS Rapid Sensor and Kidney Function Diagnostics toward first approvals and early market penetration.”

MCRA’s role extends beyond regulatory advice to include reimbursement, pricing and distribution strategy, supporting Nexsen’s broader commercial planning.

In the background, Nexsen’s development activities continue to advance, supported through the company’s technology platform which combines ultra-bright nanoparticles, high-affinity bioreceptors and modular lateral flow architecture.

The next phase of progress for Nexsen will rely on clinical results and early regulatory engagement, particularly through pre-submission dialogue with the US FDA, and the company’s positioning across two large and well-defined diagnostic markets provides a clear strategic context for these efforts.

While regulatory pathways are highly structured and can vary in duration, Nexsen’s coordinated approach to clinical validation, regulatory planning and commercial readiness suggests a measured progression toward intended market entry milestones.

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