Latest Biomarkers News

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.

Entropy Neurodynamics has expanded its global intellectual property portfolio with a South African patent for psilocybin-based fibromyalgia treatment, covering broad therapeutic methods and extending protection to 2043.

INOVIQ Ltd has revealed significant sample quality problems in its EXO-OC ovarian cancer diagnostic study, prompting a technical review and a refined development approach while maintaining its dual commercialisation strategy.

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.