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Nexsen Limited ( (AU:NXN) ) just unveiled an announcement.
Nexsen has set out a staged global rollout for its StrepSure® rapid GBS test, combining a defined U.S. 510(k) regulatory pathway with early market initiatives in Asia-Pacific and selected emerging markets. The company is developing an integrated clinical and regulatory program using data from Australia and the U.S., while progressing its Quality Management System toward ISO 13485 certification and preparing reimbursement strategies across major jurisdictions.
In the U.S., Nexsen is targeting an FDA submission in late 2026, supported by pre-submission alignment with regulators, hospital partnerships, and a contracted CRO to run a multi-site clinical program. In parallel, Hong Kong is being developed as the first commercial launch market to generate early revenue and real-world validation, with similar local validation and manufacturing partnerships advancing in Malaysia, India, and selected African markets through collaborations with public health and funding institutions.
More about Nexsen Limited
Nexsen Limited is an ASX-listed medical technology company focused on maternal and neonatal health diagnostics. Its lead product, StrepSure®, is a rapid Group B Streptococcus (GBS) sensor intended to replace slow, lab-dependent testing and support faster, point-of-care decision-making for clinicians in key global markets.
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Technical Sentiment Signal: Strong Sell
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