Latest Pathology 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.

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.

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.

Australian Clinical Labs reported a modest revenue dip but achieved growth in earnings and margins in 1H26, while updating FY26 guidance and addressing wage increases mandated by the Fair Work Commission.

Invex Therapeutics reports a net loss of $715,582 for H1 2026 while advancing its Exenatide program targeting neurological diseases, alongside notable board reshuffles.