Latest Medical 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.

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.

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.

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.

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.

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.

BlinkLab’s smartphone-based Dx1 autism screening technology has been selected for Morocco’s government-funded national early screening program, marking a major milestone in digital health adoption and autism care.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

Rhythm Biosciences has completed the first commercial sale of its ColoSTAT® blood test for colorectal cancer, confirming the full clinical and logistical process is operational and ready for expansion.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.