Latest Diagnostics News

Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.

Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.

Telix Pharmaceuticals delivered a strong 56% revenue increase in 2025, driven by U.S. sales of Illuccix and the launch of Gozellix, while advancing its therapeutic pipeline and expanding global manufacturing capabilities. Despite a net loss, the company is investing heavily in R&D and sustainability initiatives aligned with climate-related disclosures.

Sonic Healthcare has reported a robust half-year performance, with revenue climbing 16.6% to A$5.45 billion and net profit rising 10.9%, underpinned by organic growth and key acquisitions. The company maintains its full-year guidance amid ongoing US business rationalisation.

Beamtree Holdings Limited reported a 2% rise in total revenue and a reduced net loss in the first half of FY26, driven by a 10% increase in recurring revenue. The company is advancing AI-powered healthcare products and has initiated a strategic review to unlock shareholder value.

Rhythm Biosciences reported a $2.26 million half-year loss as it advances ColoSTAT into commercialisation and expands geneType partnerships, signalling a pivotal phase for the ASX-listed medical diagnostics company.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

INOVIQ Limited reported a $3.96 million net loss for H1 2026, driven by increased R&D spend, while securing $10.2 million to accelerate its exosome-based cancer diagnostics and therapeutics pipeline.

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Healius Limited reported solid half-year results for 1H26, with revenue growth driven by pathology and Agilex Biolabs, alongside significant progress in digital transformation and AI integration.

BCAL Diagnostics reported a slight revenue decline and a persistent net loss in its half-year results, with auditors flagging concerns over its ability to continue without additional funding.