Latest Pathology News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

Rhythm Biosciences has moved ColoSTAT and geneType into commercial use, recording its first sales during FY2026. But with sales revenue of just $85,339, a $5.93 million loss and an auditor-flagged going-concern uncertainty, the next phase will be judged on cash generation and repeat adoption.

Sonic Healthcare delivered a strong FY2026, with underlying net profit up 17% to A$621 million and dividends rising to A$1.08 per share. The next test is whether US efficiencies, LADR synergies and organic growth can offset Swiss fee cuts, a delayed UK contract ramp-up and heavier investment demands.

Microba shareholders would own about 67% of an enlarged Genetic Signatures under a proposed all-scrip merger valued at approximately A$51 million. The deal combines roughly A$29.6 million of FY2026 revenue and identifies up to A$3 million in potential annual cost synergies, but remains subject to a long list of approvals.

Proteomics International has begun a controlled release of two Promarker diagnostic tests through Healius in Western Australia and the Northern Territory. National commercial sales are targeted for Q2 FY27, but uptake and revenue remain difficult to estimate at this early stage.

Optiscan Imaging has reached an 84-case milestone in its live digital pathology study with Australian Clinical Labs, testing the InForm platform across a broad range of tissue types and disease settings. The data may support future regulatory submissions and commercial discussions, but the announcement does not disclose diagnostic accuracy metrics or regulatory approval.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Microba Life Sciences delivered a mixed FY26, with overall revenue slipping 5.8% to $14.76 million and a statutory loss widening 38.7% to $20.7 million. The company’s strategic pivot to core microbiome testing paid off with a 92% surge in core testing revenue and record test volumes in Australia and the UK. Despite the headline loss, underlying loss improved 11% thanks to cost cuts and AI-driven efficiencies. Microba is gearing up for the October launch of its GI Navigator diagnostic and targeting cash flow break-even on a run-rate basis in calendar 2027.

Rhythm Biosciences marked its transition to commercialisation with first sales of ColoSTAT® and geneType™ tests, despite a 55% increase in loss to $5.93 million. The company expanded market access and secured manufacturing agreements, while NHS England began evaluating ColoSTAT® for bowel cancer screening.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

Genetic Signatures (ASX: GSS) and Microba Life Sciences (ASX: MAP) are in early talks about merging to form a larger infectious disease diagnostics entity, combining rapid pathogen detection with microbiome profiling. The proposed group would have FY2026 pro forma revenue of around A$29 million and a stronger financial footing.