Latest Pathology News

BCAL Diagnostics has embedded referral forms for its early cancer detection tests into clinical software used by 97% of Australian GPs, launched a telehealth platform, and opened a Sydney clinic, gearing up for a multi-cancer test launch in June 2026.

Healius updates FY26 guidance with modest earnings growth, flags wage cost pressures from Fair Work ruling, and initiates sale process for high-growth Agilex Biolabs.

BCAL Diagnostics appoints Anne-Louise Arnett as CEO effective June 2026, aiming to accelerate its commercial rollout and international market entry of early cancer detection tests.

Noxopharm’s SOF-16 active ingredient demonstrated potent anti-inflammatory activity in patient-derived samples of systemic lupus erythematosus and rheumatoid arthritis, advancing its Sofra™ platform beyond topical applications.

Rhythm Biosciences marked a pivotal shift from development to commercial diagnostics in Q3 FY26, recording its first ColoSTAT® clinical sale and initiating NHS England evaluation while expanding geneType™ partnerships across Asia and Australia.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

Alterity Therapeutics has secured FDA alignment on the chemistry and manufacturing controls for its ATH434 Phase 3 trial in Multiple System Atrophy, marking a pivotal regulatory milestone ahead of the planned mid-2026 End-of-Phase 2 meeting.

Invex Therapeutics reported promising preclinical findings on Exenatide’s effects in a human Alzheimer's disease model, alongside a steady cash position and reduced operating outflows in Q3 FY26.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

Australian Clinical Labs has been hit with a class action lawsuit linked to a 2022 cyberattack on Medlab Pathology, alleging breaches of consumer law and duty of care. The company denies the claims and plans a vigorous defence.

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.