Latest Cancer Diagnostics News

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

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.