Latest Diagnostics News

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.

Atomo Diagnostics has responded to an ASX price query following unusual trading activity, denying any undisclosed price-sensitive information while acknowledging a related FDA update involving Lumos Diagnostics.

4DMedical’s advanced lung imaging technology CT:VQ™ has been deployed at the Mayo Clinic, marking the sixth top US academic medical centre to adopt the system within seven months of FDA clearance.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Integral Diagnostics has confirmed Jason Martinez will take over as Managing Director and CEO in August 2026, with Dr Ian Kadish remaining in charge until then to ensure a smooth transition.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

Radiopharm Theranostics reports promising second interim Phase 2b results for RAD 101, showing 90% concordance with MRI in detecting brain metastases and encouraging sensitivity and specificity trends.