Latest Point Of Care Diagnostics News

Universal Biosensors updates investors on a shift from a secured loan to a potential entitlement offer, signaling evolving funding strategies and extended timelines.

Atomo Diagnostics has secured a US$410,000 order from Lumos Diagnostics for its Pascal test cassettes, following Lumos's exclusive six-year US distribution deal for the FebriDx test with PHASE Scientific.

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.

Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

Atomo Diagnostics has successfully closed a Share Purchase Plan and secured shareholder approval for a Tranche 2 Placement, raising a combined $1.53 million to support its ongoing operations.

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a fifth contractor, covering more than 70% of US Medicare payments and advancing its commercial reach.

Lumos Diagnostics has secured its largest single US purchase order for its rapid respiratory test FebriDx, signaling growing adoption in American healthcare settings.

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.