Nexsen (ASX:NXN) commences FDA engagement as US regulatory pathway comes into focus

Nexsen has provided a business update outlining progress on regulatory, leadership and scientific fronts as the company advances its GBS Rapid Sensor toward early entry into the United States market.

The update centers on the commencement of engagement with the US Food and Drug Administration through the lodgement of a pre-submission, alongside continued clinical work and internal capability building, offering clearer visibility on the company’s near term regulatory pathway.

Highlights

• FDA engagement commenced following lodgement of a pre-submission for the GBS Rapid Sensor
• Pre-submission lodged ahead of schedule under the FDA 510(k) diagnostic pathway
• FDA feedback expected within approximately 70 days
• Clinical trials advancing across multiple hospital sites
• Appointment of a Chief Financial Officer to support financial management and market rollout activities
• Scientific leadership recognised through an RMIT Distinguished Professorship appointment

Nexsen has lodged a pre-submission with the FDA for its GBS Rapid Sensor, formally initiating the regulatory engagement process required for US market entry. The pre-submission was lodged ahead of schedule and falls under the FDA 510(k) diagnostic pathway, which applies to medical diagnostics rather than therapeutic products.

The company has stated that written FDA feedback is expected within approximately 70 days and will inform the subsequent formal 510(k) submission, which is intended to be supported by validation data from ongoing clinical trials.

The GBS Rapid Sensor is designed to deliver lab grade diagnosis in minutes at the point of care.

Nexsen has positioned the technology as addressing a critical clinical need in maternal care, where existing testing relies on laboratory processing and delayed results.

Rapid detection of Group B Streptococcus supports diagnosis at the time of labour, allowing for more timely clinical decision making.

The company confirmed that clinical trials are progressing across multiple hospital sites as part of the pathway toward regulatory submission.

Managing Director Mark Muzzin said the company’s regulatory approach was focused on efficiency within the diagnostics framework, noting that

“our strategic approach to the regulatory pathway positions Nexsen to achieve market clearance significantly faster than traditional therapeutic development”.

The comment was made in reference to the structure of the 510(k) process and the use of clinical validation data, rather than therapeutic style multi phase trials.

Alongside regulatory progress, Nexsen has appointed Richard Jarvis as Chief Financial Officer, initially in a fractional capacity.

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.

The appointment is intended to support disciplined financial management, commercial readiness, market rollout activities and international expansion as the company advances its diagnostics platform.

Scientific capability remains a core component of Nexsen’s strategy.

Chief Innovation Officer Professor Vipul Bansal has been awarded the title of RMIT Distinguished Professor, one of the university’s highest academic honours.

The recognition reflects his contributions to nanotechnology, biosensing and applied medical diagnostics, and underpins the scientific foundation supporting the company’s GBS Rapid Sensor and broader diagnostics pipeline.

Beyond its lead diagnostic, Nexsen continues to develop rapid point of care tests targeting Acute Kidney Injury and Chronic Kidney Disease, conditions that affect more than 850 million people globally and remain reliant on slow, lab based diagnostics.

The company has also indicated further diagnostics are in development across human health, ag tech and biosecurity.

Taken together, the update outlines a sequence of defined regulatory steps, ongoing clinical activity and leadership strengthening.

With FDA engagement now underway and feedback expected within a stated timeframe, Nexsen has articulated a clearer view of its immediate regulatory pathway while continuing to build the operational and scientific capability required to support its diagnostics platform.

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