Latest Diagnostics News

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

Genetic Signatures Ltd reported a robust 71% jump in quarterly sales to $2.9 million, fueled by strong respiratory testing demand in Australia and key US commercial contracts. The company is advancing its automation and instrument customisation strategy to streamline molecular diagnostics offerings.

Microba Life Sciences reported robust Q3 FY25 growth in its microbiome diagnostic tests, led by MetaXplore and MetaPanel, while advancing its therapeutics pipeline and projecting strong full-year revenue growth.

Microba Life Sciences reports robust growth in microbiome diagnostic testing across Australia and the UK, while advancing US market entry plans and transitioning its Therapeutics business to a partnering model.

INOVIQ Limited reports significant progress in its exosome-based cancer diagnostics and therapeutics, including expanded customer adoption, advanced AI screening tests, and strategic partnerships with leading research centres.

Optiscan Imaging Ltd has revealed its next-generation InForm™ pathology imaging device and strengthened its executive team, while reporting a robust cash position supported by a $1.775 million R&D tax refund for the quarter ended 31 March 2025.

Control Bionics reports its strongest US revenue in years alongside Australia’s best quarter since 2022, propelled by new product launches and strategic investments.

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

4DMedical Limited reports a 103% surge in year-to-date revenue, secures major contracts with leading healthcare providers, and advances its CT:VQ™ technology towards FDA clearance.

Radiopharm Theranostics has bolstered its cash position with an $8 million placement from Lantheus Holdings, now its largest shareholder. New clinical data highlight promising advances in brain metastases detection and HER2-targeted radiopharmaceutical therapies.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.