Latest Pathology 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.

Alterity Therapeutics has secured encouraging regulatory feedback from the FDA on its ATH434 Phase 3 program for Multiple System Atrophy, marking a critical step towards pivotal trial initiation.

BCAL Diagnostics is expanding access to its Avantect pancreatic and ovarian cancer blood tests across Australia through partnerships with major pathology providers. This move marks a significant step in making early cancer detection more widely available.

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.

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.

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.

Opthea Limited reports a striking turnaround with a $339.9 million profit for H1 2026, driven by a strategic refocus on developing OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women. The company plans a rebrand and ASX reinstatement as it charts a new course in rare respiratory health.

Patrys Limited reported a near doubling of its half-year loss to $3.02 million, driven by restructuring and a strategic pivot including the acquisition of Reliis Pty Ltd. The company is advancing a dual-platform biotech strategy combining a clinical-stage CNS asset with its proprietary antibody platform.

Sonic Healthcare has reported a robust half-year performance, with revenue climbing 16.6% to A$5.45 billion and net profit rising 10.9%, underpinned by organic growth and key acquisitions. The company maintains its full-year guidance amid ongoing US business rationalisation.

Rhythm Biosciences reported a $2.26 million half-year loss as it advances ColoSTAT into commercialisation and expands geneType partnerships, signalling a pivotal phase for the ASX-listed medical diagnostics company.

Healius Limited reported solid half-year results for 1H26, with revenue growth driven by pathology and Agilex Biolabs, alongside significant progress in digital transformation and AI integration.