Latest Cancer Diagnostics News

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

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.

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.

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.

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.

Telix Pharmaceuticals reported a robust 63% revenue increase in H1 2025, driven by commercial growth and strategic investments, while advancing key clinical trials and maintaining full-year guidance.

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.