Latest Diagnostics News

Rhythm Biosciences has inked a non-exclusive distribution agreement with 4Cyte Pathology to integrate its ColoSTAT® colorectal cancer blood test into a vast pathology network across eastern Australia, aiming to boost adoption and accessibility.

Clarity Pharmaceuticals’ Cu-64 SAR-bisPSMA diagnostic agent significantly outperformed the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence, more than doubling lesion and patient detection rates in a pivotal head-to-head trial.

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

Pro Medicus Limited reported a robust half-year performance, with underlying profit after tax rising by approximately 30%, driven by significant new sales and strategic implementations. The company remains confident in its proprietary technology's resilience against AI disruption while expanding its market footprint.

Pro Medicus Limited has reported a stellar half-year performance with revenue up 28.4% and a surge in net profit, driven by major US contract wins and strategic investments.

Waratah Minerals reveals promising early-stage geometallurgical results from its Spur Zone, showing gold recoveries exceeding 90% through conventional processing methods. The findings highlight coarse, free milling gold, suggesting a straightforward path to efficient extraction.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

Atomo Diagnostics has landed a significant $630,000 order to supply HIV self-tests for a federally funded Australian health initiative, reinforcing its role in expanding accessible testing.

Genetic Signatures has appointed Anne Lockwood as interim Managing Director, bringing extensive financial expertise to guide the company through a critical transition period.

BCAL Diagnostics has launched its Avantect blood tests for pancreatic and ovarian cancer with encouraging early uptake and is advancing its BREASTESTplus breast cancer test towards broader clinical use.

Cyclopharm Limited is accelerating its US market push for Technegas with a A$16 million capital raise following a record 2025 sales performance. The company aims to expand its US installations and advance new clinical applications beyond pulmonary embolism.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.