Nexsen clears quality hurdle as StrepSure advances towards FDA review

ISO 13485 certification covers StrepSure manufacturing

Nexsen Limited (ASX:NXN) has cleared a key quality-system hurdle for StrepSure, securing ISO 13485:2016 certification across the diagnostic’s design, development and manufacture. The assessment was conducted by the British Standards Institution, a global standards and certification body.

For a medical-device developer, this is more than a badge for the corporate presentation. ISO 13485 is an internationally recognised quality standard used in regulatory submissions and expected by hospitals, distributors and commercial partners. Nexsen said the certification provides the system needed to move StrepSure from development towards regulatory approval and commercial supply.

MDSAP alignment supports the planned FDA pathway

The company’s quality management system also meets the requirements of the Medical Device Single Audit Program, or MDSAP. That framework is recognised by regulators including the US Food and Drug Administration and Australia’s Therapeutic Goods Administration, although the certification itself is not an FDA or TGA market authorisation.

The timing matters because Nexsen is preparing its US regulatory submission after the FDA submission target shift moved to early 2027 following product work identified in interim clinical review. The new certification removes one quality-system requirement from that process, but the submission, regulatory review and any subsequent clearance remain outstanding.

Hong Kong positioned as Asia-Pacific launch hub

Nexsen said the certified manufacturing scope positions it to supply StrepSure under an internationally recognised system as it prepares for an Asia-Pacific launch. Hong Kong is intended to serve as the initial commercial entry point and regional hub for manufacturing and distribution, with the company targeting distributors, hospital networks and commercial partners across the region.

The company cited approximately 132 million births worldwide each year as the scale of the potential testing opportunity for its Group B Streptococcus diagnostic. That figure, sourced to the United Nations’ World Fertility Report 2024, describes the broad population underpinning the opportunity rather than StrepSure sales, market share or cleared demand.

Certified framework extends to future diagnostics

Nexsen said the documented processes and templates established through the quality management system can also support other products in its pipeline, including diagnostics for acute kidney injury and chronic kidney disease. That could reduce the need to build a separate quality infrastructure for each programme, though the filing gives no timeline or financial estimate for those products.

The immediate test is execution: converting certification into an FDA submission, securing relevant regional approvals and establishing the manufacturing and distribution arrangements required for launch. ISO 13485 makes those next steps more credible operationally; it does not determine whether the device will clear regulators or generate commercial revenue.