Latest Diagnostics News

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

Atomo Diagnostics has appointed Dr Cheri Walker as interim CEO, replacing founder John Kelly who steps down after 15 years. The leadership change aligns with the company's shift towards commercial growth in the US and Europe.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

Healius Limited posted a modest revenue increase and underlying loss improvement for FY26, overshadowed by a substantial non-cash goodwill impairment and ongoing sector pressures.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

ResMed Inc. posted a 10% rise in fiscal 2026 revenue to $5.65 billion, bolstered by the acquisition of Noctrix Health and an agreement to sell its MatrixCare business. The company continues to invest in AI-powered digital health solutions amid ongoing patent litigation and a shifting regulatory landscape.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

Proteomics International has achieved a key patent acceptance in Australia for its PromarkerEndo blood test, reinforcing its intellectual property portfolio and commercialisation strategy in a major healthcare market.

Integral Diagnostics (ASX: IDX) posted strong preliminary FY26 results with revenue nearing $790 million and operating EBITDA up 30%, while announcing Jenny Martin as incoming CFO amid leadership transitions.

Imricor Medical Systems has ignited its US commercial operations with rapid adoption by top pediatric hospitals, buoyed by FDA pediatric clearances and clinical trial progress.

Clarity Pharmaceuticals has presented compelling clinical evidence that its investigational 64Cu-SAR-bisPSMA diagnostic and 67Cu-SAR-bisPSMA therapeutic candidates outperform current standards in prostate cancer care, positioning the company for regulatory and commercial milestones.