6 January 2026 – Sydney, Australia | Nexsen Limited (ASX:NXN) has announced the commencement of formal engagement with the United States Food and Drug Administration (FDA) as it advances its rapid Group B Streptococcus (GBS) point-of-care diagnostic toward market entry into the world’s largest maternal health market.
The Company has lodged a Pre-Submission with the FDA for its GBS Rapid Sensor, marking the start of the regulatory process for US market entry and achieved ahead of schedule. The pre-submission has been made under the FDA’s 510(k) diagnostic pathway, which provides a defined and near-term regulatory route compared with the longer timelines typically associated with therapeutic or vaccine development.
Nexsen expects written feedback from the FDA within approximately 70 days, which will inform the Company’s subsequent formal 510(k) submission, with clearance to be supported by validation data from Nexsen’s ongoing multi-site clinical trials.
The United States represents the largest global maternal health market, with approximately 3.7 million births per year. Nexsen’s GBS Rapid Sensor is designed to deliver lab-grade diagnostic results in minutes at the point of care, addressing a critical unmet clinical need where current testing often relies on delayed laboratory results. Rapid detection at the time of labour supports more timely clinical decision-making and has the potential to improve outcomes for mothers and newborns.
Nexsen’s Managing Director, Mark Muzzin, commented: “We're pleased to announce our FDA pre-submission lodgement as we advance toward our 510(k) submission. Our strategic approach to the regulatory pathway positions Nexsen to achieve market clearance significantly faster than traditional therapeutic development, which requires multi-phase clinical trials and extended timelines. With robust clinical data from our multi-site trials and FDA feedback on our validation approach, we're well-positioned for efficient US market entry and to deliver real-world impact in diagnostics”.
Alongside regulatory progress, Nexsen has also strengthened its commercial and financial readiness with the appointment of Mr Richard Jarvis as Chief Financial Officer, initially in a fractional capacity. Mr Jarvis brings more than 25 years of executive finance and accounting experience, including 18 years in CFO roles at ASX and dual-listed ASX–AIM companies. His background supports Nexsen’s preparation for commercial rollout, capital markets engagement and international expansion.
Nexsen has also received external recognition for its scientific leadership. Chief Innovation Officer Professor Vipul Bansal has been awarded the prestigious title of RMIT Distinguished Professor, one of the University’s highest academic honours. The award recognises Professor Bansal’s global leadership in nanotechnology, biosensing and applied medical diagnostics, and his ability to translate research into real-world impact. His work underpins Nexsen’s diagnostics platform, including the GBS Rapid Sensor and the Company’s broader pipeline.
Together, these developments reinforce Nexsen’s execution against its strategy and provide greater clarity around the near-term regulatory and commercial pathway as the Company advances toward US market entry.
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About Nexsen Limited (ASX:NXN)
Nexsen is developing a suite of rapid point-of-care diagnostics that deliver lab-grade results for conditions that have traditionally relied on delayed lab testing. The company focuses on areas of significant unmet clinical need, where faster answers can improve patient outcomes and reduce pressure on healthcare systems.
Nexsen’s lead diagnostic is the GBS Rapid Sensor, a rapid point-of-care diagnostic for detecting Group B Streptococcus, addressing a critical unmet need in maternal health. The company is also developing rapid kidney function tests for Acute Kidney Injury and Chronic Kidney Disease, two conditions that affect more than 850 million people globally and remain underserved by slow, lab-based diagnostics.
With further diagnostics in development across human health, ag-tech and biosecurity, Nexsen aims to become a global leader in rapid point-of-care diagnostics, delivering on its mission to ensure every person benefits from a Nexsen test at some point in their life.
Contact details:
Jane Morgan Management
jm@janemorganmanagement.com.au