Latest Diagnostics News

Atomo Diagnostics has landed a significant $450,000 order to supply HIV self-tests for a federally funded Australian program aimed at increasing at-home testing among high-risk groups.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

PainChek Limited has secured a pivotal reseller and integration deal with Eldermark Software, positioning its AI-driven pain assessment app for a major US market rollout pending FDA approval.

Optiscan Imaging Ltd has reached a pivotal milestone with the completion of its cloud-based telepathology software MVP, enabling secure, real-time remote collaboration for digital pathology.

4DMedical has submitted its CT:VQ™ software to the FDA, aiming to revolutionize lung ventilation and perfusion imaging by replacing traditional nuclear scans with a non-contrast CT-based solution.

Rhythm Biosciences has successfully validated its second-generation ColoSTAT® Beta assay, confirming its readiness for commercial application in colorectal cancer detection. The Beta kit offers improved precision and faster turnaround times compared to its predecessor.

Proteomics International has validated its PromarkerEndo blood test as a highly accurate, non-invasive diagnostic tool for endometriosis, with commercial launch planned in Australia for Q3 2025. The test promises to reduce the average seven-year diagnostic delay by providing a simple risk score applicable across all disease stages.

Omega Oil and Gas has confirmed an extensive oil and gas system in Queensland’s Taroom Trough through high-quality logging at its Canyon-2 well, with DFIT testing now underway to further evaluate reservoir potential.

Microba Life Sciences reveals breakthrough data showing its MetaPanel™ test detects elusive gastrointestinal pathogens in 20% of chronic cases, enabling targeted treatment and complete symptom resolution.

EMVision Medical Devices has enhanced its AI-powered stroke diagnostic algorithm, achieving a notable 95% sensitivity and 80% specificity in recent tests. This progress sets the stage for upcoming pivotal trials and regulatory milestones.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Atomo Diagnostics has released a Target Market Determination for a new capital raising involving options and shares, including a $1 million Share Purchase Plan and placement offer. The move targets eligible Australian shareholders and aims to bolster the company’s financial position amid a speculative investment environment.