Latest Diagnostics News

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.

Atomo Diagnostics stands to gain significantly as Lumos Diagnostics’ FebriDx test secures FDA CLIA waiver approval, vastly expanding its US market potential. This regulatory milestone triggers substantial contracted revenues and prompts Atomo to ramp up production.

Genetic Signatures is undertaking a major organisational restructure to cut costs by $5 million and sharpen its commercial focus, aiming to accelerate growth in its diagnostic product offerings.

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

4DMedical has achieved CE Mark certification for its groundbreaking CT:VQ™ ventilation-perfusion imaging technology, unlocking the vast European market. The company also raised $83 million to fund rapid expansion across the EU.

BCAL Diagnostics is expanding access to its Avantect pancreatic and ovarian cancer blood tests across Australia through partnerships with major pathology providers. This move marks a significant step in making early cancer detection more widely available.

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.