Nexsen and FlashDx Propose Joint Venture for Enhanced GBS Test
Key points
- Joint venture to develop enhanced molecular GBS test
- Builds on existing CE-marked GBS test
- Accelerates market entry in Asia-Pacific
Full summary
Nexsen Limited has announced a proposed 50:50 joint venture with FlashDx Shenzhen Inc. to develop and commercialize an enhanced molecular Group B Streptococcus (GBS) diagnostic test. The joint venture will leverage FlashDx's existing CE-marked GBS test as the foundation, incorporating further product development to improve detection at low bacterial levels. Nexsen will fund and lead the regulatory program for the enhanced joint venture product, including planned US FDA 510(k) clearance and conformity under the European Union In Vitro Diagnostic Medical Devices Regulation (CE-IVDR). The enhanced joint venture product is intended for hospital and intrapartum testing, expanding Nexsen's GBS market opportunity by addressing different healthcare settings, workflows, and price points.
Outlook
The joint venture aims to accelerate Nexsen's commercial strategy and expand its GBS testing offering into a distinct molecular market.
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