Highlights

• Nexsen decided not to lodge the current StrepSure configuration with the US FDA and will enhance the device first.

• The FDA submission, previously targeted for the fourth quarter of 2026, is now expected to slip by about one quarter.

• A completed interim review reported no adverse safety signal, with enrolment suspended in line with the study protocol.

• A non-dilutive federal grant of A$500,000 backs an RMIT-led project adapting Nexsen's GBS sensor into a newborn test.

Nexsen Limited (ASX:NXN) has chosen a slower route to the US market for its StrepSure test, preferring a refined device to a quick submission. Shares were trading at A$0.160 on 23 October 2026, up 6.67%. The company said on 23 September 2026 that it will not lodge the current StrepSure configuration with the US Food and Drug Administration, and will first build in lessons from its clinical study.

Why the Filing Moved

StrepSure is a rapid test designed to detect Group B Streptococcus, or GBS, in pregnant women. A predefined interim review of the clinical study is complete, and enrolment has been suspended as the protocol requires. Nexsen said no adverse safety signal or event was reported.

The study's location shaped the findings. GBS prevalence at the Northern Health site in Melbourne was about 11%, compared with 18% to 25% at many US sites. Fewer GBS-positive cases were captured as a result, and the bar for avoiding false positives was higher. The FDA submission, previously targeted for the fourth quarter of 2026, is now expected to slip by about one quarter. Nexsen said the planned enhancements are not expected to need material additional development spending.

Three Planned Upgrades

The company outlined three development initiatives. The first is a magnetic-bead step to concentrate GBS from swab samples. The second is quantitative electronic readout using upconversion nanoparticle reader technology. The third is a dual-recognition architecture that uses two independent methods to identify GBS.

The revised timing applies only to the US pathway. Development of StrepSure for antenatal screening and decentralised care in the Asia-Pacific continues, with the University of Hong Kong supporting clinical validation and Gleneagles Hospital Hong Kong acting as a hospital partner. Nexsen said its other programs, covering kidney disease, traumatic brain injury, neonatal sepsis and biosecurity, and its commercial strategy are proceeding as planned.

A Newborn Test in the Pipeline

Earlier in the year, on 27 January 2026, Nexsen announced it would act as commercialisation partner on a project led by RMIT University under the Commonwealth's AEA Ignite program. The project would adapt the maternal GBS rapid sensor into a point-of-care test for newborns, targeting both early-onset and late-onset infections.

Total project value is A$1,029,538. The Commonwealth contributes a non-dilutive grant of A$500,000, Nexsen contributes A$100,000 in cash and A$100,000 in kind, and RMIT adds A$329,538 in kind. Over the following year the project aims to validate the device's analytical and pilot clinical performance and to show the platform can support other biomarker-based diagnostics. Nexsen said the project extends its GBS program without significant cash outlay.

Contract Update and Next Steps

On 24 September 2026 Nexsen's securities were suspended from quotation at its request, pending an announcement about the execution of a contract for an additional device. The suspension was due to last until the contract announcement or the start of trading on 25 September 2026, whichever came first.