How Nexsen’s Rapid GBS Sensor Could Transform Maternal Health Diagnostics

Nexsen Engages FDA Ahead of Schedule

Nexsen Limited (ASX – NXN) has taken a significant step forward in its ambition to enter the US maternal health diagnostics market by lodging a pre-submission with the US Food and Drug Administration (FDA) for its rapid Group B Streptococcus (GBS) sensor. This early engagement under the FDA’s 510(k) pathway signals a streamlined regulatory approach, potentially accelerating market clearance in a sector where timely diagnosis can be critical.

The GBS rapid sensor offers lab-grade results within minutes at the point of care, addressing a pressing clinical need. Current testing methods often involve delays due to laboratory processing, which can hinder timely intervention during labour. Nexsen’s technology aims to fill this gap by enabling immediate detection, thereby supporting better clinical decisions and outcomes for mothers and newborns.

Strategic Regulatory and Commercial Progress

Unlike traditional therapeutic products that require lengthy multi-phase clinical trials, Nexsen’s diagnostic device benefits from a more direct regulatory pathway. The company expects to receive FDA feedback within approximately 70 days, which will inform the finalisation of its clinical validation program and subsequent formal 510(k) submission. This proactive approach could see Nexsen achieve US market clearance in a fraction of the time typically required for new medical products.

Complementing its regulatory progress, Nexsen has strengthened its commercial leadership by appointing Richard Jarvis as Chief Financial Officer. Jarvis brings over 25 years of executive finance experience, including extensive roles in ASX-listed companies, and will play a key role in preparing Nexsen for market rollout and international expansion. His global experience aligns well with Nexsen’s ambitions to establish a presence beyond Australia, targeting markets in the US, UK, Asia, and Africa.

Scientific Leadership Recognised

Adding to the company’s momentum, Nexsen’s Chief Innovation Officer, Professor Vipul Bansal, has been honoured with a Distinguished Professorship by RMIT University. This accolade recognises his pioneering work in nanobiotechnology and biosensing, which underpins Nexsen’s rapid diagnostics platform. Professor Bansal’s leadership not only enhances Nexsen’s scientific credibility but also signals the company’s commitment to innovation in healthcare technology.

With ongoing clinical trials at multiple hospital sites, Nexsen is gathering robust validation data to support its regulatory submissions. The company’s broader pipeline includes rapid diagnostics for kidney function, targeting conditions that affect hundreds of millions globally, further illustrating its potential to impact healthcare delivery significantly.