Latest Cancer Diagnostics News

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.

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.

INOVIQ Limited clarifies recent share price movements, confirming no undisclosed material information while highlighting an imminent ASCO presentation and provisional patent application tied to its EXO-OC ovarian cancer test.

Rhythm Biosciences has successfully validated its second-generation ColoSTAT® Beta assay, confirming its readiness for commercial application in colorectal cancer detection. The Beta kit offers improved precision and faster turnaround times compared to its predecessor.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.