Latest Cancer Diagnostics News

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.

Pacific Edge has successfully raised NZ$16 million through an upsized equity placement, surpassing its initial target and setting the stage for a planned NZ$5 million Share Purchase Plan. The funds aim to accelerate clinical and commercial milestones, including regaining Medicare coverage for its cancer diagnostic tests.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.