Latest Diagnostics News

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.

4DMedical has renewed its three-year contract with the University of Michigan Medical Center, reinforcing its foothold in US respiratory imaging. Alongside, a pivotal clinical study validates its technology’s ability to detect early lung disease, while a substantial Australian grant boosts its AI research.

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

Clarity Pharmaceuticals has successfully completed recruitment for its pivotal Co-PSMA Phase II trial, testing its novel Cu-SAR-bisPSMA diagnostic against the current standard in detecting prostate cancer recurrence. This milestone advances their mission to improve early detection and treatment outcomes for men with low PSA levels.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

Pacific Edge Limited (ASX – PEB) has announced a securities purchase plan (SPP) aiming to raise up to NZD 5 million, contingent on shareholder approval of a prior NZD 16 million placement. The move is designed to bolster working capital amid ongoing growth initiatives.