Highlights

  • Non-binding term sheet signed for a 50:50 joint venture with FlashDx Shenzhen Inc.
  • The venture targets an enhanced molecular Group B Streptococcus test for hospital and labour-ward use
  • Nexsen is to lead and fund US FDA 510(k) and CE-IVDR work and lead Asia-Pacific sales outside China
  • StrepSure reached a study interim review, with the US submission expected to move back by about one quarter
  • Binding agreements and a detailed business plan are still to be negotiated

Nexsen (ASX:NXN) describes itself as a diagnostics company using nano-biotechnology to improve point-of-care testing, with a platform combining aptamer-based sensitivity and AI-driven biomarker discovery. Its lead product is StrepSure, a rapid lateral-flow screen for Group B Streptococcus (GBS). ASX announcements released on 24 and 25 September 2026 updated the StrepSure program and introduced a proposed joint venture with FlashDx Shenzhen Inc.

Term Sheet With FlashDx

According to the 25 September 2026 announcement, Nexsen signed a non-binding term sheet with FlashDx Shenzhen for a 50:50 joint venture. The venture would develop and commercialise an enhanced molecular GBS test built on FlashDx's existing CE-marked GBS Test, with a Nexsen sample-preparation enhancement intended to release more GBS material from each sample.

The ASX:NXN release stated that FlashDx would provide the molecular platform, manufacturing capability, clinical trial materials and exclusive supply of the test. Nexsen would lead the regulatory program and fund approvals for US FDA 510(k) clearance and CE-IVDR conformity, and would lead sales across Asia-Pacific markets outside China. Profits would be shared equally.

Intellectual Property and Next Steps

Under the proposed terms, FlashDx would transfer its GBS cartridge-specific intellectual property to the venture once approvals are obtained, while keeping its platform, device, reader and other background intellectual property.

The ASX:NXN announcement noted that a detailed business plan and binding agreements are still required, including a joint venture agreement and a manufacturing and supply agreement. Nexsen also expects to negotiate distribution agreements and start the US regulatory program, supported by three US clinical sites it has already engaged. Hong Kong is the initial regional focus and India a significant target market, subject to local regulatory requirements.

StrepSure Program Update

In its 24 September 2026 announcement, Nexsen reported that the StrepSure study at Northern Health in Melbourne, which tested women in labour, reached a predefined interim review. Enrolment was suspended per protocol and no adverse safety signal or event was reported.

The company stated that it will not submit the current StrepSure configuration to the US FDA and will first make targeted improvements, including a magnetic-bead concentration step, a quantitative electronic reader and a dual-recognition design. The previously targeted Q4 2026 submission is expected to move back by about one quarter, and the enhancements are not expected to need material additional development spending. GBS prevalence at the trial site was about 11%, compared with 18% to 25% at many US sites.

According to the company, the molecular test targets hospital and intrapartum testing, whereas StrepSure targets antenatal screening and decentralised care.

Key Insights

The confirmed facts are the non-binding term sheet and the revised StrepSure timeline. Because the term sheet is non-binding, ASX:NXN has not yet entered a definitive joint venture, and no completion dates were given.

Regulatory outcomes for both products, including FDA 510(k) clearance and CE-IVDR conformity, remain uncertain and depend on future submissions. The ASX:NXN announcement's market background, including about 132 million births globally each year, is the company's own context rather than an outcome of the proposed venture.