Latest Cancer Diagnostics News

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.

Pacific Edge reports steady demand for its Cxbladder cancer diagnostic tests despite losing Medicare coverage and transitioning US customers to a new test. The company is advancing clinical evidence and a $21 million capital raise to support growth and regain coverage.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

BCAL Diagnostics has secured a strategic partnership with Cancer Care Associates to fast-track the clinical adoption and revenue generation of its innovative BREASTEST plus™ breast cancer blood test starting FY2026.

Rhythm Biosciences has obtained a $1 million non-dilutive loan backed by its FY2025 R&D Tax Incentive rebate, aiming to accelerate the commercial rollout of its ColoSTAT® test and expand its geneType™ platform.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Rhythm Biosciences has regained NATA accreditation for its geneType laboratory, a key step toward commercialising its ColoSTAT® cancer risk test as an in-house diagnostic.

Clarity Pharmaceuticals has partnered with SpectronRx to manufacture and distribute its lead prostate cancer diagnostic, Cu-64 SAR-bisPSMA, at commercial scale across the US. This agreement sets the stage for a seamless launch pending FDA approval.

Clarity Pharmaceuticals’ novel PET imaging agent Cu-SAR-Bombesin demonstrated safety and effectiveness in detecting prostate cancer recurrence missed by standard scans in its Phase II SABRE trial. The agent identified lesions in about one-third of patients with negative or equivocal standard imaging.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.