Latest Cancer Diagnostics News

Imagion Biosystems has made significant progress towards filing an Investigational New Drug application for its MagSense® HER2 breast cancer imaging agent, receiving encouraging feedback from the FDA and preparing for a Phase 2 clinical trial.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

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.