Latest Diagnostics News

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

4DMedical confirms its partnership with AstraZeneca in Brazil and announces a new contract supporting Australia’s National Lung Cancer Screening Program, signaling strategic growth in respiratory imaging.

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

Artrya Limited has raised A$75 million through a two-tranche placement and launched a A$5 million share purchase plan to fast-track the U.S. commercialisation of its AI-powered Salix platform following FDA clearance.

Proteomics International Laboratories announces the planned retirement of its founder and Managing Director, Dr Richard Lipscombe, in February 2026, marking a pivotal leadership transition as the company seeks a new CEO to drive its next growth phase.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Rewardle Holdings reported a modest revenue increase for FY25 but saw its loss more than double, driven by investments in AI-powered MedTech associate CloudHolter and expanded platform initiatives.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Proteomics International has unveiled new clinical data confirming its PromarkerEso blood test can accurately detect early stages of esophageal adenocarcinoma, potentially transforming screening for a cancer with poor prognosis.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

ABx Group’s latest ANSTO leach tests confirm over 70% extraction of critical heavy rare earths dysprosium and terbium from its Deep Leads project, reinforcing its path to producing a mixed rare earth carbonate sample by year-end.