Latest Diagnostics News

Lumos Diagnostics Holdings Limited (ASX: LDX) has opened a Share Purchase Plan (SPP) offering eligible shareholders the chance to invest up to A$30,000 at A$0.225 per share, accompanied by free options. The SPP aims to raise up to A$2 million and closes on 24 April 2026.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

Lumos Diagnostics has entered a three-year contract manufacturing agreement with Micro-Pak to produce the Mold Analyzer system, marking a transition from development to commercial-scale manufacturing with an initial US$250,000 purchase order.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Archer Materials has progressed its Biochip program by completing the alpha prototype and Stage 1 project with IMEC, now advancing to develop a beta prototype suitable for external use and clinical validation.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.

Lumos Diagnostics has secured its largest-ever order for FebriDx® following FDA clearance, signalling a major expansion in the US market opportunity.

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.

Nexsen Limited's subsidiary has won a HK$6 million grant to accelerate clinical validation and manufacturing of its rapid Group B Streptococcus diagnostic in Hong Kong, positioning the city as a key Asia-Pacific hub.