Latest Diagnostics News

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

Imricor Medical Systems saw a sharp 69.5% decline in revenue for 2025, driven by clinical trial impacts, yet narrowed its net loss to $25.3 million as it secured FDA clearance for key products post-year-end.

TrivarX Limited reported a $1.26 million half-year loss as it completed the acquisition of Stabl-Im brain imaging IP and validated its mental health screening technology in veterans. The company raised $4.2 million to fund clinical development and expand its diagnostic portfolio.

Integral Diagnostics Limited has reported a robust half-year performance, with revenues soaring 55.6% and EBITDA nearly doubling, driven by strong patient volume growth and successful integration of Capitol Health. The company also declared a fully franked interim dividend of 3.3 cents per share.

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.