Nexsen (ASX:NXN) announced an acceleration of its global commercialisation strategy for StrepSure, its proprietary rapid sensor designed to detect Group B Streptococcus.
The company is currently navigating a dual-track approach, prioritising a formal US regulatory submission while simultaneously initiating early market entry across the Asia-Pacific and other emerging regions.
A critical milestone was achieved this month with the confirmation of a defined 510(k) regulatory pathway following positive engagement with the US Food and Drug Administration.
The clinical strategy, which incorporates a robust dataset from both Australian and American trials, has received FDA concurrence.
Nexsen is now targeting a formal submission in the final quarter of 2026.
The company’s quality management system is undergoing rigorous validation, with ISO 13485 certification and MDSAP expansion anticipated by early Q3 2026.
Managing Director Mark Muzzin emphasised that StrepSure addresses a dire unmet clinical need, as GBS remains a leading cause of neonatal injury globally.
"The current standard of care relies on slow, lab-dependent testing," Muzzin noted, "depriving clinicians of key information when they need it most."
By adopting a staged rollout, Nexsen aims to generate early revenue and gather real-world validation data ahead of its primary US market entry.
At the time of reporting, Nexsen's share price was $0.19.