Latest Diagnostics News

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

Archer Materials has achieved a significant milestone by integrating its graphene-based sensors with silicon readout circuitry, paving the way for a compact, at-home potassium testing device aimed at chronic kidney disease management.

Invion Limited reports no adverse events and early lesion reduction in its Phase I/II non-melanoma skin cancer trial, advancing to dose optimization.

INOVIQ Limited clarifies recent share price movements, confirming no undisclosed material information while highlighting an imminent ASCO presentation and provisional patent application tied to its EXO-OC ovarian cancer test.

Emyria reports sustained six-month improvements in treatment-resistant PTSD patients and announces a strategic research collaboration with Australian National University to advance mental health care models.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

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.