Latest Cancer Diagnostics News

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.

BCAL Diagnostics has launched its first commercial breast cancer diagnostic test, BREASTESTplus™, in Australia, marking a key milestone despite a $7.24 million loss for FY2025. The company is also advancing its US operations with a new subsidiary and clinical trials underway.

Clarity Pharmaceuticals reported a $64.3 million loss for FY2025 alongside significant clinical progress and a $203.6 million placement to fund its radiopharmaceutical pipeline expansion.

Rhythm Biosciences has formalised a strategic co-marketing partnership with the Know Your Lemons Foundation to promote its geneType Breast Cancer Risk Assessment Test, expanding access to early detection tools for women in the US and Australia.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.

BCAL Diagnostics has partnered with Sonic Healthcare Australia to broaden access to its innovative blood-based breast cancer test, BREASTEST plus™, across Sydney. This move formalizes a commercial rollout following successful trials and aims to improve early detection for women with dense breast tissue.

Rhythm Biosciences has completed critical validation of its ColoSTAT colorectal cancer assay and submitted it for ISO15189 accreditation, paving the way for commercialisation. The test demonstrated strong clinical performance, highlighting its potential as a non-invasive diagnostic tool.

INOVIQ Limited reported a $6.9 million net loss for FY25 while making significant strides in its exosome-based cancer diagnostics and therapeutics pipeline, including a breakthrough ovarian cancer screening test and promising CAR-exosome therapy results.

Rhythm Biosciences has launched a $3.75 million placement alongside an offer of over 52 million new options, all contingent on shareholder approval. The move aims to bolster working capital as the company advances its cancer diagnostic products.

Rhythm Biosciences is raising up to $3.75 million through a share placement to fund the launch of its ColoSTAT® colorectal cancer diagnostic and accelerate commercialization of its geneType™ portfolio.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.