Latest Cancer Diagnostics News

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

Rhythm Biosciences has completed the first commercial sale of its ColoSTAT® blood test for colorectal cancer, confirming the full clinical and logistical process is operational and ready for expansion.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Rhythm Biosciences has inked a pivotal distribution agreement with UK-based Digistain Limited to introduce its geneType™ genetic test portfolio in Southeast Asia, starting with the Philippines. This marks Rhythm’s first commercial foothold in the region, setting the stage for broader expansion.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

INOVIQ Limited reported a $3.96 million net loss for H1 2026, driven by increased R&D spend, while securing $10.2 million to accelerate its exosome-based cancer diagnostics and therapeutics pipeline.

Rhythm Biosciences has inked a non-exclusive distribution agreement with 4Cyte Pathology to integrate its ColoSTAT® colorectal cancer blood test into a vast pathology network across eastern Australia, aiming to boost adoption and accessibility.