Latest Diagnostics News

Synertec has identified ANSTO as the client behind its $45.5 million engineering contract, with about $36 million of revenue expected during the first 26 months. The project could improve FY27 revenue, but the company has not yet revised its guidance.

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.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.

Manuka Resources has reported several high-grade, shallow gold intersections from its Pipeline Ridge drilling campaign, led by 32 metres at 7.98 grams per tonne. The results support a maiden resource estimate, but metallurgy, true widths and resource classification remain unresolved.

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.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

EMVision is progressing its CRC-P funded Regional Benefits Study to evaluate the emu™ bedside brain scanner in remote hospitals, aiming to speed up stroke diagnosis where CT access is limited. Site visits are complete, and protocol development is underway, with relevance extending to similar rural hospitals in the US.

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

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.

Atomo Diagnostics lifted revenue 41% to AUD 5.33 million for FY26, cutting its loss by 29% to AUD 3.51 million, driven by HIV self-testing growth and a key US partnership. Leadership changes signal a strategic pivot as the company eyes global expansion.