Key Highlights

  • Nexsen (ASX:NXN) shares were up 11.54% at $0.145 during the 22 October 2026 session, while the S&P/ASX 200 was down 0.64%.
  • In its 25 September 2026 release, Nexsen announced a non-binding term sheet with FlashDx Shenzhen Inc. for a 50:50 joint venture for a molecular GBS test.
  • Nexsen would lead and fund the planned US FDA 510(k) and European CE-IVDR pathways, with Hong Kong and India named as priority markets.

Nexsen Limited (ASX:NXN) shares were up 11.54% at $0.145 during the Trading session on Thursday 22 October 2026. At 11:55 am, the S&P/ASX 200 stood at 8,774.90, down 0.64% (56.40 points), while the All Ordinaries stood at 8,897.80, down 0.66%. Nexsen is a Sydney-based developer of rapid point-of-care diagnostics, with lead programmes in Group B Streptococcus (GBS) testing in maternal health and in kidney function.

About the Company

Nexsen Limited is listed on the ASX under the code NXN and operates from Suite 1005, 4 Bridge Street, Sydney, New South Wales. The company develops a growing portfolio of rapid point-of-care diagnostics for serious conditions where delays in diagnosis can affect patient outcomes and limit clinicians' ability to make fast treatment decisions.

Nexsen is supported by a growing international research, clinical and commercial network across Australia and Asia. Managing Director Mark Muzzin leads the company.

Business Overview

Nexsen's lead programmes include diagnostics for GBS in maternal health, and for kidney function targeting Acute Kidney Injury and Chronic Kidney Disease. It is also advancing programmes across traumatic brain injury, neonatal sepsis and biosecurity.

StrepSure is its rapid lateral-flow GBS programme for antenatal screening and decentralised care. Over the past six months, the company has set up research facilities in Hong Kong and in Partnership with Universiti Malaya, and signed its first hospital partnership through IHH Healthcare's Gleneagles Hospital Hong Kong.

Proposed FlashDx Joint Venture

In an ASX release dated 25 September 2026, Nexsen announced a non-binding term sheet with FlashDx Shenzhen Inc. to establish a 50:50 joint venture. The venture would develop and commercialise an enhanced molecular GBS diagnostic based on FlashDx's existing CE-marked GBS Test.

The enhanced product is intended for hospital and intrapartum testing, which Nexsen describes as a different clinical setting from StrepSure, with the two products aimed at different workflows and price points. Nexsen would contribute a sample-preparation enhancement designed to release more GBS material from each sample, making low bacterial levels easier to detect.

Test Technology and Regulatory Pathways

The 25 September 2026 release said FlashDx has developed a proprietary, fully automated real-time PCR system. Its CE-marked test detects GBS from vaginal swab samples in an enclosed, sample-to-answer system, with results in under one hour. It detects two genetic markers and includes built-in quality control.

The parties intend to pursue US FDA 510(k) clearance and CE-IVDR conformity for the enhanced product. Nexsen would lead the regulatory programme and provide the agreed funding, and three US clinical sites already engaged by Nexsen are intended to support the US work. FlashDx would Supply the platform, Manufacturing and clinical trial materials.

Structure and Asia-Pacific Plans

Under the term sheet, a new company would be owned equally. FlashDx would exclusively manufacture and supply the test, and would transfer cartridge-specific intellectual property into the venture once regulatory approvals are obtained, while retaining its platform and background intellectual property. The parties would share profits equally.

Hong Kong is expected to be an initial focus, and India is named as a Target market subject to its local regulatory pathway. Nexsen is expected to lead sales across Asia-Pacific markets outside China.

Related Sector Context

Point-of-care diagnostics aim to deliver test results near the patient rather than through a central laboratory. In GBS, the company notes that screening is typically performed at 36 to 37 weeks of pregnancy and that colonisation can change before labour. It cites about 132 million births globally each year and carriage in roughly 10% to 30% of pregnant women. GBS can cause serious infections in newborns, including sepsis, pneumonia and meningitis.

At the time of the data, the S&P/ASX 200 was down 0.64% and the All Ordinaries down 0.66%, while Nexsen shares were up 11.54%.

Risks to Weigh In

The term sheet is non-binding, and the joint venture remains subject to the parties agreeing a detailed Business plan and binding transaction documents, including a shareholders' agreement and a manufacturing and supply agreement.

Both the US FDA 510(k) clearance and CE-IVDR conformity for the enhanced product are still to be obtained, and Nexsen is to fund the regulatory programme. Entry into India depends on the applicable local regulatory pathway. The company's disclaimer also notes that forward-looking statements are subject to risks beyond its control.

Catalysts on Watch

The parties said they will now progress definitive joint venture, manufacturing, supply, Marketing and distribution agreements while beginning planning for commercial market entry and the US regulatory programme.

Further milestones include the start of the FDA and CE-IVDR work, commercial planning for Hong Kong and India, and developments across Nexsen's other programmes.

Putting It Together

Nexsen shares were up 11.54% to $0.145 during the 22 October 2026 session as the benchmarks traded lower. The company's most recent major update, dated 25 September 2026, outlined a proposed joint venture with FlashDx that remains subject to binding agreements.