Latest Clinical Validation News

BCAL Diagnostics has partnered with US-based ClearNote Health to exclusively distribute innovative blood tests for early detection of pancreatic and ovarian cancers in Australia and New Zealand, starting early 2026.

Proteomics International Laboratories has achieved ISO 15189 certification for its Australian lab, marking a pivotal step in commercialising its precision diagnostic tests like PromarkerD and PromarkerEso.

EBR Systems has achieved a significant commercial milestone with its tenth US implant of the WiSE wireless cardiac pacing system, setting the stage for broader market adoption supported by new reimbursement schemes.

EVE Health Group has appointed Dr Fiona Cousins as the inaugural member of its Scientific Advisory Board, reinforcing its commitment to advancing treatments for dysmenorrhoea and endometriosis ahead of the commercial launch of Dyspro™.

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

Artrya Limited has raised A$75 million through a two-tranche placement and launched a A$5 million share purchase plan to fast-track the U.S. commercialisation of its AI-powered Salix platform following FDA clearance.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Proteomics International has unveiled new clinical data confirming its PromarkerEso blood test can accurately detect early stages of esophageal adenocarcinoma, potentially transforming screening for a cancer with poor prognosis.

4DMedical has bolstered its financial footing with a $6 million R&D tax incentive and a $10 million strategic investment, while its XV LVAS® technology gains clinical validation for predicting serious COPD treatment complications.

Biome Australia has partnered with Green Cross Health to launch its Activated Probiotics across New Zealand’s largest pharmacy network, marking a pivotal step in its international growth strategy.

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.