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Nexsen (ASX:NXN) has hit a key milestone in the global rollout of its StrepSure system with backing from the US Food and Drug Administration (FDA).
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StrepSure is the first commercial application of Nexsen’s diagnostic platform, with a successful rollout expected to validate the company’s ability to develop and commercialise rapid, point-of-care diagnostics at scale.
The platform features an unmet test for the detection of Group B streptococcus (GBS) in pregnant women. GBS affects an estimated 18% of pregnant women globally and, if undetected and untreated, can lead to serious neonatal complications including sepsis, pneumonia and meningitis.
MD, Mark Muzzin, said GBS is one of the most consequential unmet clinical needs in maternal and neonatal health globally.
“It is a leading cause of serious neonatal injury or death. The current standard of care relies on slow lab-dependent testing, depriving clinicians of key information when they need it most. Our GBS rapid sensor, StrepSure, is designed to change that,” he said.
“With our FDA regulatory pathway now confirmed this month, we are excited to unveil our global roll-out strategy, which has been structured to accelerate clinical adoption in key markets and generate opportunities for early revenue as we advance towards our FDA clearance.”
The company’s execution of a global rollout strategy for a defined US regulatory pathway is defined toward US regulatory submission and early market entry initiatives underway across the Asia-Pacific and emerging markets.
The positive pre-submission engagement with the FDA is supported by clinical, regulatory, manufacturing and commercial workstreams which are progressing in parallel, positioning the company to deliver a consistent pipeline.
Mr Muzzin said Nexsen’s execution pathway supports expansion into additional indications already in development, including renal diagnostics, bovine mastitis and biosecurity applications, each targeting large, underserved markets reliant on slow or fragmented testing.
He added that with clinical, regulatory and commercial workstreams progressing across multiple regions, Nexsen is positioned to deliver a steady pipeline of milestones over the next six to 12 months as it advances toward initial commercialisation and broader platform deployment.
As part of the rollout Nexsen has commenced early work on reimbursement and payer strategies across multiple jurisdictions, including the US, ensuring proactive alignment with payers from the outset.
NXN is up 9.09% to 18.0¢. Mkt cap $33.03M.
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