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Nexsen Clears FDA Hurdle, Paving Way for StrepSure® in US Maternal Health Market
8:36am on Monday 23rd of March, 2026 AEDT
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Healthcare
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Nexsen Clears FDA Hurdle, Paving Way for StrepSure® in US Maternal Health Market
8:36am on Monday 23rd of March, 2026 AEDT
Key Points
Positive FDA feedback on regulatory strategy and clinical validation
De-risked pathway toward US market authorisation for StrepSure®
StrepSure® offers rapid point-of-care testing for Group B Streptococcus
Milestone validates Nexsen’s broader diagnostic platform
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