Latest Cancer Diagnostics News

BCAL Diagnostics has secured national ethics approval to establish a large-scale registry tracking the clinical impact of its BREASTESTplus blood test for breast cancer diagnosis, aiming to enhance doctor adoption and reimbursement prospects.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

BCAL Diagnostics is preparing to launch its Avantect® pancreatic and ovarian cancer blood tests in Australia by January 2026, following key regulatory approvals and promising clinical data. The company also broadens the reach of its BREASTESTplus™ breast cancer test, targeting a larger segment of women with dense breast tissue.

Cleo Diagnostics has identified a significantly larger U.S. patient population for its pre-surgical ovarian cancer test, expanding its commercial opportunity ahead of next year’s market entry.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.

TrivarX Limited has exercised its option to acquire the innovative Stabl-Im brain imaging technology, aiming to revolutionize early detection of brain tumours pending shareholder approval.

Clarity Pharmaceuticals has bolstered its financial position with a $203 million institutional placement and reported positive Phase II trial results for its lead prostate cancer diagnostic, Cu-SAR-bisPSMA. The company also expanded its pipeline with promising preclinical data on a pan-cancer agent and secured a key copper-67 supply agreement to support future commercialisation.

BCAL Diagnostics has secured key partnerships and a $10 million convertible note facility to expand its cancer detection tests across Australia and New Zealand, marking steady commercial progress in Q3 2025.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

Rhythm Biosciences reports strong Q1 FY26 progress, securing strategic partnerships and advancing commercial readiness for its ColoSTAT® colorectal cancer test alongside robust growth in its geneType platform.