Latest Diagnostics News

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Axel REE Limited has achieved a key operational milestone in its in situ recovery (ISR) development at the Woolrich deposit within the Caladão Project, confirming strong rare earth element leach performance under low-impact magnesium sulphate conditions.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.

Proteomics International Laboratories has slashed a quarter of its workforce and appointed a new CFO amid a strategic pivot to commercial diagnostics, aiming to save over $1 million annually and sharpen execution.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

Genetic Signatures has locked in a 10-year supply deal with Denmark’s Hvidovre Hospital for its EasyScreen™ Pan-Enteric assay, marking a significant step in its European expansion. The agreement covers 28,000 tests in the first year with growth expected, leveraging the company’s proprietary 3base® technology to streamline complex gastrointestinal pathogen detection.

Telix Pharmaceuticals has initiated a US$550 million convertible bonds offering to refinance existing 2029 bonds and support general corporate purposes, securing low-cost, non-dilutive financing with a conversion premium above current share price.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.