Latest Diagnostics News

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

BCAL Diagnostics has partnered with US-based ClearNote Health to exclusively distribute innovative blood tests for early detection of pancreatic and ovarian cancers in Australia and New Zealand, starting early 2026.

Proteomics International Laboratories has achieved ISO 15189 certification for its Australian lab, marking a pivotal step in commercialising its precision diagnostic tests like PromarkerD and PromarkerEso.

CloudHolter Pty Ltd reported a substantial $39.7 million net loss for FY2025 amid ongoing cash outflows but continues to raise capital through convertible notes as it targets an IPO by year-end.

Artrya Limited has completed the first tranche of its A$75 million placement, raising approximately A$60 million to advance its AI-driven coronary artery disease platform. Eligible shareholders can now participate in a Share Purchase Plan at the same price.

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

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.