Nexsen Launches Clinical Trial for StrepSure® GBS Sensor, Eyeing 2026 Market Entry
Nexsen Limited has initiated clinical trials for its StrepSure® GBS Rapid Sensor, a next-generation diagnostic device aimed at improving maternal health outcomes. The trial's success could pave the way for regulatory approval and early market penetration by the second half of 2026.
- Clinical trial underway at Northern Hospital, Victoria
- Device targets rapid detection of Group B Streptococcus in expectant mothers
- Led by renowned maternal-fetal medicine expert Prof. Lisa Hui
- Potential market launch and regulatory approvals targeted for 2H 2026
- Global commercial rollout strategy including US FDA submission
Clinical Trial Marks a Milestone
Nexsen Limited, an Australian nano-biotechnology company, has commenced clinical trials for its flagship diagnostic device, the GBS Rapid Sensor, branded as StrepSure®. This trial, conducted at the Northern Hospital in Epping, Victoria, represents a critical step in validating the device’s clinical efficacy and operational readiness within busy labour wards.
The StrepSure® device is designed to rapidly detect Group B Streptococcus (GBS) bacteria in expectant mothers at the point of care. GBS is a significant concern in maternal health, as it can be transmitted to newborns during birth, potentially causing severe illness or death. Current screening methods require testing weeks before labour, which can miss changes in GBS status by delivery. Nexsen’s innovation aims to provide real-time, lab-grade diagnostics that allow clinicians to make immediate and informed decisions on antibiotic use and clinical management.
Expert Leadership and Clinical Credibility
The trial is led by Professor Lisa Hui, a globally recognised authority in maternal-fetal medicine. Her involvement lends significant clinical credibility to the program and underscores the potential impact of the technology on maternal and newborn health outcomes. Professor Hui highlighted the device’s ease of use and suitability for the workflow in busy labour wards, suggesting it could be widely adopted across maternity hospitals to improve efficiency and patient care.
Strategic Path to Market
Beyond clinical validation, Nexsen is actively pursuing regulatory approvals, including submissions to the US Food and Drug Administration (FDA), and preparing for scaled manufacturing. The company envisions early market penetration as soon as the second half of calendar year 2026, with a global commercial rollout planned. The StrepSure® trademark reinforces Nexsen’s commitment to establishing market leadership in maternal diagnostics.
With an estimated 132 million births worldwide annually and approximately one in five pregnant women carrying GBS, the market opportunity is substantial. If successful, StrepSure® could replace current standards of care, offering a faster, more accurate, and accessible diagnostic alternative that benefits mothers, infants, and healthcare systems alike.
Looking Ahead
The clinical trial’s outcomes will be closely watched by investors and healthcare stakeholders. Positive results could accelerate Nexsen’s commercialisation timeline and validate its broader biosensing platform, which has applications beyond maternal health. However, as with all medical innovations, regulatory hurdles and market adoption remain key challenges.
Bottom Line?
Nexsen’s StrepSure® trial could redefine maternal diagnostics, but clinical and regulatory milestones remain ahead.
Questions in the middle?
- Will the clinical trial data meet the benchmarks needed for regulatory approval?
- How will Nexsen navigate competitive pressures in the maternal diagnostics market?
- What are the timelines and risks associated with scaling manufacturing for global rollout?
