21 October 2025 – Melbourne, Australia | Nexsen Limited (ASX:NXN), a nano-biotechnology company pioneering next-generation technology in point-of-care diagnostics, has announced the commencement of a pivotal clinical trial for its GBS Rapid Sensor, which is going to be marketed under the proprietary name StrepSure®.
The clinical trial marks a significant step in the validation of Nexsen’s diagnostic platform and will support the Company’s commercialisation roadmap, including its upcoming regulatory submissions and early market penetration, which could take place as soon as the second half of the 2026 calendar year.
The clinical trial is being conducted at the Northern Hospital in Epping, Victoria, where expectant mothers are currently being enrolled and tested. The trial will be overseen by internationally recognised maternal and fetal medicine expert, Professor Lisa Hui.
Nexsen’s Managing Director, Mark Muzzin, commented:
“The successful completion of this trial will validate Nexsen’s commercialisation strategy for the GBS Rapid Sensor, which will be marketed as StrepSure® upon launch. We are advancing our regulatory pathway, scaled production planning and global commercial rollout of our flagship diagnostic technology.
“Today marks a significant milestone for Nexsen and our partnership with RMIT University, as we initiate the first clinical trial of a diagnostic device developed using Nexsen’s proprietary biosensor platform. This progress highlights our growing readiness to deliver next-generation diagnostic tools to the healthcare market at scale.
“If proven in clinical trials, StrepSure® has the ambition and potential to replace the current standard of care for screening Group B Streptococcus in expectant mothers, enabling timely intervention and substantially improving the health and wellbeing of mothers and infants.”
Commenting on the trial commencement, Prof. Hui said:
“We’re excited to commence this clinical trial in the labour wards at Northern Health, marking an important step toward improving care for mothers and babies. Current GBS screening is forced to be undertaken weeks before labour because it relies on time-consuming pathology testing, yet GBS status can change by the time a woman gives birth.
“The Nexsen Rapid GBS Sensor is designed to support accurate, point-of-care testing during labour, with the potential to make GBS detection more precise, optimise antibiotic use, shorten hospitalisation, and deliver savings for the Australian healthcare system.
“So far, we’ve found the device simple to use and well-suited to the workflow of busy labour wards. It’s rewarding to see this Australian innovation evaluated in a real clinical setting, and we look forward to seeing the full outcomes. A technology like this could be adopted across maternity hospitals, improving efficiency and outcomes nationwide.”
About StrepSure® GBS Rapid Sensor
The StrepSure® GBS Rapid Sensor is a rapid diagnostic device with lab-grade accuracy, designed for use at the point of care during labour with expectant mothers. The test detects the presence of Group B Streptococcus (GBS), which is a leading cause of neonatal sepsis, meningitis, and pneumonia. The device uses Nexsen’s nano-biotechnology platform to deliver accurate, real-time results at-bedside, offering a faster alternative to traditional laboratory testing, which is often delayed and less adaptable to changes in maternal GBS status prior to birth taking place.
The clinical trial has been registered with the Australia and New Zealand Clinical Trials Register (ANZCTR) and has been approved by the Royal Children’s Hospital Melbourne Human Research Ethics Committee. An initial batch of 1,000 investigational StrepSure® devices has been manufactured in an ISO 13485 certified facility and delivered for use in the study.
With approximately 132 million births occurring globally each year and an estimated one in five pregnant women carrying GBS, Nexsen believes the market potential for its platform is substantial. In addition to preparing for submission to the US FDA, Nexsen is actively exploring various international markets as part of its go-to-market strategy.
About Professor Lisa Hui
Professor Lisa Hui (MBBS, PhD, FRANZCOG, CMFM) is an internationally recognised leader in maternal–fetal medicine and reproductive epidemiology. She is a Dame Kate Campbell Fellow in the Department of Obstetrics and Gynaecology at the University of Melbourne and a recipient of the prestigious Norman Beischer Clinical Research Fellowship for her pioneering work to prevent infections transmitted from mothers to babies.
Professor Hui leads the Reproductive Epidemiology Group at the Murdoch Children’s Research Institute, Australia’s largest child health research institute, ranked top three globally for research quality and impact, and based at The Royal Children’s Hospital in Melbourne. Clinically, she practices as a Maternal–Fetal Medicine Specialist at The Northern Hospital and the Mercy Hospital for Women, Victoria. She is the Principal Investigator for the Nexsen Rapid GBS Sensor clinical trial, contributing her extensive expertise in maternal–child health to advance innovations that improve outcomes for mothers and newborns.
Media Enquiries
Jane Morgan Management
E: [email protected]
Corporate Enquiries
Nexsen Limited
E: [email protected]
W: nexsen.bio
Reign Advisory
E: [email protected]
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
[email protected]
