Latest Diagnostics News

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

Imricor Medical Systems has filed a Form 10 registration with the U.S. SEC, marking its transition to a U.S. reporting company amid ongoing FDA clearances and clinical trials. This move signals a significant step in its early commercialisation of MRI-guided cardiac ablation technology.

Lakes Blue Energy has temporarily halted gas flow testing at its Wombat-5 well to conduct extended pressure analysis, planning a perforation program to enhance production prospects.

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.