Latest Diagnostics News

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.

Resonance Health has received a $732,851 refund from the Australian Taxation Office, reflecting its FY2025 R&D tax incentive claim net of income tax payable. This cash inflow strengthens the company’s financial position ahead of its March quarterly report.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

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.

Micro-X has reached a key development milestone with the completion of its first Full Body CT laboratory test bench, securing a $1.6 million payment from US government partner ARPA-H and advancing its innovative medical imaging program.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.

A new clinical study from Sichuan University confirms that TruScreen’s AI-enabled cervical cancer screening combined with high-risk HPV testing outperforms traditional cytology methods, reinforcing its global potential.

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.

Radiopharm Theranostics reported a 44% increase in net loss to $27 million for the half-year ended December 2025, driven by expanded R&D spending. The company bolstered its cash reserves through a $35 million placement while progressing multiple clinical trials across its radiopharmaceutical pipeline.

Memphasys Limited has advanced its Felix™ System commercial rollout with key regulatory approvals and new international contracts, while trimming operating costs and narrowing losses in the first half of FY2026.