Nexsen Limited (ASX: NXN) (, a nano-biotechnology company developing an innovative point-of-care diagnostic platform, is pleased to announce the acceleration of its US market entry for its GBS Rapid Sensor and Kidney Function Diagnostics, with the appointment of an expert consultant advising the Company on its US FDA regulatory pathway.
Appointment of MCRA
Nexsen has appointed MCRA, a leading medical device, diagnostics, and biologics Clinical Research Organisation and advisory firm, to accelerate US market entry for the GBS Rapid Sensor and Kidney Function Diagnostics. The appointment advances Nexsen’s regulatory preparations ahead of its first US FDA engagement planned for early 2026 for the GBS Rapid Sensor—a point-of-care test for Group B Streptococcus (GBS) in expectant mothers that provides results on the day of labour in minutes.
The GBS Rapid Sensor addresses a critical unmet need, with 132 million births per year globally. Development of Nexsen’s Kidney Function Diagnostics is also well underway, with MCRA to advise on regulatory strategy and optimisation of activities toward first regulatory approvals. Chronic Kidney Disease affects approximately 700 million people globally, with Acute Kidney Injury present in 7% of all hospital admissions and 30% of all ICU admissions worldwide.
Managing Director Comment
Nexsen’s Managing Director, Mark Muzzin, commented:
“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.”
“With our GBS Rapid Sensor clinical data now being collected under the guidance of Prof. Lisa Hui, and a clear regulatory roadmap being developed, we are building strong momentum toward positioning Nexsen as a global leader in rapid, point-of-care diagnostic technology. We are working towards an initial international market access and early sales as soon as the second half of 2026 for our GBS Rapid Sensor.”
MCRA will provide strategic regulatory and clinical guidance to support Nexsen’s planned US FDA submissions and commercialisation programs. The engagement will include developing a comprehensive FDA regulatory strategy, pre-submission planning, and coordinating potential early interaction with the US FDA to facilitate an efficient path to market.
In parallel with regulatory acceleration, Nexsen is advancing commercial-readiness initiatives to bring the GBS Rapid Sensor to market in the second half of 2026. The Company is targeting early sales in selected international jurisdictions ahead of full US approval.
MCRA’s commercial and reimbursement advisory divisions will support Nexsen in evaluating pricing, reimbursement, and distribution strategies to maximise first-mover advantage across maternal health markets. This will also inform the broader rollout of Nexsen’s Kidney Function Diagnostics suite, which targets acute and chronic kidney disease applications across both at-home and hospital environments.
Comment from MCRA
Commenting on their engagement by Nexsen, Director of IVD Regulatory Affairs, Dr Natasha Griffin of MCRA, said:
“MCRA is honoured to support Nexsen’s development of their GBS Rapid Sensor and to play a role in the future of their diagnostic pipeline. We look forward to the continued partnership – exciting times ahead.”
The collaboration follows the commencement of Nexsen’s first clinical trial for the GBS Rapid Sensor, led by Professor Lisa Hui, a globally recognised authority in maternal-fetal medicine. Clinical data generated from this program will underpin FDA submission and broader international regulatory filings.
Using Nexsen’s innovative nano-biotechnology, the GBS Rapid Sensor enables real-time, point-of-care testing, providing rapid identification of Group B Streptococcus (GBS) bacteria in expectant mothers on the day of labour, in minutes, not days.
Kidney Function Diagnostic Development
Nexsen is also developing rapid, point-of-care diagnostics for the screening, detection, and ongoing monitoring of various subsets of Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI). A rapid and accurate diagnosis of a patient’s kidney status is critical—whether in the ambulance, intensive care unit, or at home. CKD is estimated to affect approximately 700 million people globally, with a prevalence of 11% to 14% in countries such as the United States, Australia, the United Kingdom, and India. AKI is particularly prevalent in hospitalised patients, with estimates of 7% of all hospital admissions and 30% of ICU admissions globally. In context, there are approximately 5.7 million ICU admissions in the US annually.
The availability of a rapid, cost-effective, point-of-care diagnostic test for these patients would enable more frequent monitoring of kidney health and facilitate earlier identification and initiation of treatment. With MCRA’s guidance, Nexsen aims to optimise and accelerate its regulatory and commercialisation strategy, exploring the potential for accelerated regulatory approval pathways for these diagnostic tools in the US.
About MCRA
MCRA is a leading, industry-specialised, multi-service, employee-based, integrated business that assists clients throughout the technology life cycle, from research and development through commercialisation. The company provides services to a wide range of organisations in the healthcare industry, including start-ups, leading healthcare organisations, financial investors, and global manufacturers. MCRA’s core clientele spans medical devices and diagnostics, with a concentrated focus on neuro-musculoskeletal healthcare, orthopaedics, cardiology, biologics, imaging, and in vitro diagnostics.
About us:
About Nexsen Limited (ASX: NXN)
Nexsen is a nano-biotechnology company developing a next-generation biosensing platform that combines ultra-bright nanoparticles, high-affinity bioreceptors, and modular lateral flow architecture to deliver lab-quality diagnostics in a low-cost, user-friendly format. Nexsen’s focus is on applications of its platform technology where there is a significant unmet need in a globally significant market.
Nexsen’s lead product is the GBS Rapid Sensor, a rapid, point of care diagnostic tool for the detection of Group B Streptococcus in expectant mothers. Other products in development target various applications across human health, ag-tech, and biosecurity.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
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