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Nexsen Advances StrepSure FDA Pathway and Secures Asia-Pacific Grants

10:18am on Tuesday 28th of April, 2026 AEST Healthcare
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Nexsen Advances StrepSure FDA Pathway and Secures Asia-Pacific Grants

10:18am on Tuesday 28th of April, 2026 AEST
Key Points
  • FDA Q-Submission confirms 510(k) pathway for StrepSure
  • HK$6 million IGNITE grant supports Hong Kong clinical validation and manufacturing
  • AU$0.5 million grant funds neonatal Group B Streptococcus diagnostic development
  • ISO 13485 Quality Management System certification progressing toward completion
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