Latest Point Of Care Testing News

Lumos Diagnostics has reached a key enrolment milestone in its BARDA-backed FebriDx paediatric trial, unlocking a US$670,000 payment and advancing its FDA submission pathway to expand use in children aged 2-12 years.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Lumos Diagnostics has entered a three-year contract manufacturing agreement with Micro-Pak to produce the Mold Analyzer system, marking a transition from development to commercial-scale manufacturing with an initial US$250,000 purchase order.

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

Archer Materials has made significant strides in its quantum computing and medical diagnostics programs, including improved carbon qubit readout and clinical-standard silicon biochips, while securing key partnerships and maintaining a strong cash position.

Nexsen Limited has won a $500,000 non-dilutive grant to extend its rapid Group B Streptococcus diagnostic technology into neonatal care, opening a significant new market opportunity.

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.

AnteoTech Ltd reports a strong FY2025 with doubled sales revenue, strategic partnerships, and key product milestones in battery materials and life sciences diagnostics.

Atomo Diagnostics has successfully placed $416,611.77 from its Share Purchase Plan shortfall, bolstered by a recent US order from Lumos Diagnostics. This capital injection strengthens Atomo’s position as it scales up production of its Pascal cassettes.

Atomo Diagnostics reports strong commercial momentum in Q4 FY25, highlighted by a major US supply agreement, rapid growth in HIV self-test sales, and promising data for its syphilis test.