Latest Diagnostics News

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

Singular Health has landed a pivotal $2 million US pilot contract with Provider Network Solutions and completed an $8 million capital raise, advancing its medical imaging platform’s regulatory and product development milestones.

Alterity Therapeutics has published a peer-reviewed study introducing the MSA Atrophy Index, a novel MRI-based biomarker that enhances diagnosis and monitoring of Multiple System Atrophy, potentially transforming clinical trials and patient care.

Integral Diagnostics has been served with a legal claim from vendors disputing the earn out valuation of its Imaging Queensland acquisition, despite an independent expert's prior valuation. The company plans to defend the claim, which could have financial and reputational implications.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase to $204 million in Q2 2025, launched its new prostate cancer imaging agent Gozellix in the U.S., and advanced key clinical trials despite an ongoing SEC inquiry.

Microba Life Sciences reports strong Q4 FY25 growth driven by record microbiome test sales and clinician adoption in Australia and the UK, while advancing its therapeutics pipeline and targeting regional break-even in FY26.

Microba Life Sciences reports record Q4 FY25 microbiome test sales in Australia and the UK, underpinned by landmark clinical studies and a $14.5 million capital raise. The company is transitioning away from legacy products to focus on high-value diagnostics, positioning for sustained growth in FY26.

Genetic Signatures reported steady quarterly sales of $4.4 million, reflecting seasonal demand in Australia, while restructuring its US operations to accelerate growth. A new US contract and strategic partnerships signal potential for future expansion.

Genetic Signatures has formed a strategic partnership with Tecan and Repado to develop a fully automated, scalable infectious disease testing platform integrating advanced automation, compliant software, and proprietary assays.

Atomo Diagnostics has successfully placed $260,000 of the shortfall from its recent Share Purchase Plan, issuing over 14 million shares and options to sophisticated investors. This capital injection strengthens the company’s working capital position as it advances its rapid diagnostic test business.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.