ISO 13485 certification secured for StrepSure® quality system
Nexsen Limited (ASX:NXN) has achieved ISO 13485:2016 certification for its Quality Management System (“QMS”) covering the design, development and manufacture of StrepSure®, its Group B Streptococcus (“GBS”) diagnostic. Assessment was carried out by the British Standards Institution (“BSI”).
The company describes the certification as another important step in its transition from research-led development towards commercialisation.
Key points from the announcement:
- Certification covers the design, development and manufacture of StrepSure®
- The QMS meets the requirements of the Medical Device Single Audit Program (“MDSAP”)
- The certification advances StrepSure® towards its FDA submission
- The established QMS provides a quality foundation for future devices across Nexsen’s pipeline
Mark Muzzin, Managing Director
“This is a major milestone for Nexsen and a significant step on StrepSure®’s path to market…”
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Why certified manufacturing matters for the Asia-Pacific launch
Supporting distributors and hospitals
Manufacturing is included within the scope of the certification. Nexsen is therefore positioned to manufacture and supply StrepSure® under a certified quality system as it moves towards commercial launch.
This is central to the company’s Asia-Pacific strategy, with Hong Kong as its initial commercial entry point and regional hub for manufacturing and distribution. The company states that the certification strengthens its position with distributors, hospital networks and commercial partners across the region, where ISO 13485 is widely recognised.
Nexsen’s Hong Kong R&D facility reinforces this regional focus, giving the company a local research team, a HK$6 million non-dilutive grant and collaborations with leading universities in its entry market.
A large addressable market
StrepSure® is targeting a large global opportunity, with ~132 million births worldwide each year (United Nations, World Fertility Report 2024) underpinning a substantial testing opportunity.
ISO 13485 and MDSAP explained for investors
ISO 13485 is the internationally recognised quality management standard for medical devices. It is a core requirement for regulatory submissions and a standard expectation of commercial partners and distributors.
MDSAP allows a single audit to address the requirements of multiple regulators, including the US Food and Drug Administration (“FDA”) and Australia’s Therapeutic Goods Administration (“TGA”). Nexsen states its QMS meets these requirements, which supports StrepSure®’s path to the US market.
The certified QMS builds on positive FDA feedback already received through the Q-Submission program, which endorsed Nexsen’s proposed regulatory strategy and clinical validation approach for StrepSure.
In practical terms, the company says certification puts in place the quality system it needs to progress StrepSure® from development towards regulatory approval and commercial supply.
| Milestone | What it means | Investor relevance |
|---|---|---|
| ISO 13485 certification | QMS certified for design, development and manufacture of StrepSure® | A core requirement for regulatory submissions and a standard expectation of commercial partners and distributors |
| MDSAP compliance | QMS meets MDSAP requirements, allowing a single audit to address multiple regulators | Supports StrepSure®’s path to the US market and advances it towards its FDA submission |
| Manufacturing in scope | Nexsen can manufacture and supply StrepSure® under a certified quality system | Central to the Asia-Pacific strategy, with Hong Kong as the initial commercial entry point |
A quality foundation for the wider pipeline
Having established and certified its QMS, Nexsen now has an operating quality system and documented processes and templates that can be applied to other products in its pipeline, including its kidney disease diagnostics.
The company says this provides a strong foundation for future products as they advance towards regulatory and commercial development, allowing Nexsen to build on infrastructure already in place.
Management stated that, with certification in hand, its focus is on the FDA submission and launch in Asia-Pacific.
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