Latest Diagnostics News

Radiopharm Theranostics reported a A$56.3 million comprehensive loss for fiscal 2026, with operating cash outflows rising to A$52.8 million and cash falling to A$4.1 million. The company says further funding is required, while auditors flag a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

AnteoTech has set sales conversion as its FY2027 priority after FY2026 sales revenue slipped to A$460,397, while operating expenses fell sharply and cash stood at A$11.2 million. The battery materials and life sciences company says customer evaluations and partnership discussions are building, but most opportunities remain short of recurring commercial revenue.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

TrivarX has made Stabl-Im its central development bet, but the ASX-listed health technology company also reported an $8.76 million FY2026 loss and an auditor-flagged material uncertainty over its ability to continue without further funding. The planned Phase 1 study remains subject to regulatory, ethics and operational clearances.

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.

AnteoTech has received $1.905 million from the Australian R&D Tax Incentive, providing fresh cash for its battery materials and life sciences commercialisation efforts. The rebate relates to eligible research conducted during the 2026 financial year.

AnteoTech reduced its FY2026 loss and strengthened its balance sheet, but auditors warned that a material uncertainty remains over the company’s ability to continue as a going concern. Commercial revenue fell sharply as battery and diagnostics opportunities remained largely in evaluation or negotiation.

Nexsen has proposed a 50:50 joint venture with FlashDx Shenzhen to develop and commercialise an enhanced molecular Group B Streptococcus test, using an existing CE-marked platform as its starting point. The proposed venture could shorten Nexsen’s path into hospital and intrapartum testing across Asia-Pacific, but the term sheet remains non-binding and regulatory work is still ahead.

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.

Nexsen has paused its StrepSure clinical programme after an interim review identified performance improvements needed before a US FDA submission, pushing the target timetable back by roughly one quarter. Its shares were then suspended pending an announcement about a potentially material contract for an additional device.