Latest Cancer Diagnostics News

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.

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.

Rhythm Biosciences’ subsidiary Genetype has landed a pivotal 12-month contract with the University of Melbourne to provide advanced breast cancer risk assessments, marking a significant step in personalised cancer screening.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Clarity Pharmaceuticals reports a robust cash position and strategic refocus on its lead prostate cancer asset, Cu-SAR-bisPSMA, supported by multiple FDA Fast Track designations and advancing clinical trials.

INOVIQ Limited reports significant progress in its exosome-based cancer diagnostics and therapeutics, including expanded customer adoption, advanced AI screening tests, and strategic partnerships with leading research centres.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.

Telix Pharmaceuticals has gained UK MHRA approval for Illuccix, its advanced prostate cancer PET imaging agent, promising to alleviate supply shortages and improve diagnostic accuracy across the UK.

Rhythm Biosciences has fast-tracked the integration of the geneType™ business, restoring full commercial capabilities ahead of schedule and setting the stage for expanded market reach.

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

BCAL Diagnostics is poised to launch its innovative BREASTEST® breast cancer diagnostic test in early 2025, backed by recent NATA accreditation, patent acceptance, and a $2.6 million R&D tax offset.