Key Highlights

  • Nexsen Limited (ASX:NXN) shares traded at $0.125 on 21 October 2026, down 10.71%.
  • Nexsen’s latest announcement, dated 25 September 2026, covers a non-binding term sheet for a 50:50 joint venture with FlashDx Shenzhen Inc.
  • Nexsen would lead and fund US FDA 510(k) and European CE-IVDR regulatory pathways for the enhanced molecular GBS test.

Nexsen Limited (ASX:NXN) shares fell 10.71% to trade at $0.125 during the trading session on 21 October 2026, while the S&P/ASX 200 (XJO) stood at 8,809.20, down 7.70 points or 0.087%. Nexsen’s latest ASX announcement, dated 25 September 2026, covers a non-binding term sheet to establish a 50:50 joint venture with FlashDx Shenzhen Inc. for a molecular Group B Streptococcus (GBS) test.

About Nexsen

Nexsen Limited is a rapid point-of-care diagnostics company. Its StrepSure program is a rapid lateral-flow test for GBS intended for antenatal screening and decentralised care.

The proposed joint venture

The non-binding term sheet with FlashDx contemplates a 50:50 joint venture to develop and commercialise a new, enhanced molecular GBS test based on FlashDx’s existing CE-marked GBS test. FlashDx would provide molecular technology and manufacturing capability, while Nexsen would fund and lead the agreed regulatory program, including planned US FDA 510(k) clearance and conformity under the EU In Vitro Diagnostic Regulation (CE-IVDR).

Nexsen would contribute a sample-preparation enhancement designed to improve detection at low bacterial levels. The joint venture product would be used under licence.

Product positioning

The enhanced product is intended for hospital and intrapartum testing, a different setting from StrepSure’s antenatal and decentralised use, and the two products would address different workflows and price points. FlashDx’s existing test detects GBS from vaginal swab samples in a sample-to-answer system with results in under one hour, using two genetic markers and built-in quality control.

Nexsen said the approach would give it a nearer-term route to market entry in priority markets including Hong Kong and India, using its existing clinical and commercial network.

Market context

The announcement notes that GBS is carried by approximately 10–30% of pregnant women across about 132 million births globally each year, citing the World Health Organization.

FlashDx’s test uses an entraded, sample-to-answer real-time PCR system that returns results in under one hour and includes built-in quality control, an approach the announcement says matches that of a product already cleared by the FDA for use during labour. Nexsen’s contribution would be a sample-preparation enhancement aimed at improving detection at low bacterial levels.

Sector context

Group B Streptococcus testing is used around labour and delivery, and molecular tests deliver results faster than culture-based methods. Diagnostic products require regulatory clearance in each jurisdiction before sale, including FDA clearance in the United States and CE marking under the IVDR in Europe.

Joint ventures between diagnostics developers and manufacturers are one way to combine technology, regulatory and distribution capabilities.

Risks and uncertainties

The term sheet is non-binding, and a joint venture depends on definitive agreements being reached. Regulatory clearances such as FDA 510(k) and CE-IVDR conformity are not assured and can take time.

Nexsen would fund the regulatory program, which carries cost, and product development outcomes are uncertain. Market entry in Hong Kong, India and other markets depends on approvals and commercial uptake.

What's next

Nexsen’s next steps include progressing the non-binding term sheet towards definitive documentation and, if agreed, leading the FDA and CE-IVDR regulatory pathways. Further updates will follow as terms are finalised.