Latest Biomarkers News

Pacific Edge edges closer to Medicare reimbursement for its bladder cancer tests while its Asia Pacific operations show rising test volumes and improved margins, signaling a path toward profitability.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Proteomics International has won a key US patent for its PromarkerEndo blood test, bolstering its commercial foothold in the world’s largest healthcare market. The patented technology offers a non-invasive, accurate diagnosis of endometriosis, a condition that currently takes years to detect.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

CONNEQT Health Limited is offering eligible shareholders a share purchase plan to raise up to $0.5 million at a 24.3% discount, aiming to fund its next growth phase in vascular health technology.

Lumos Diagnostics has received a A$709,837 cash refund from the Australian Government’s R&D Tax Incentive, bolstering its investment in proprietary point-of-care diagnostic technologies.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial has passed a third independent safety review, endorsing continuation without changes. Final topline efficacy data is expected in November 2026.

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.

Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.