Latest Diagnostics News

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

Singular Health Group has completed a $773,000 placement with Marin and Sons, alongside exercising options and issuing shares under its employee incentive plan, strengthening its capital base.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Pacific Edge Limited reported a resilient FY25 performance despite losing Medicare coverage for its Cxbladder tests in the US, announcing a $20 million equity raise to support commercialization and growth.

TruScreen Group Limited forecasts a robust 64% increase in FY26 sales, driven by strategic market expansions and new distribution agreements. The company’s AI-enabled cervical cancer screening technology is gaining traction across emerging markets.

TruScreen Group Limited has announced a NZ$3 million capital raise to fund strategic growth initiatives across Asia and Africa, alongside repaying existing debt. The raise includes a placement and share purchase plan with free attaching options, signaling confidence in its expanding cervical cancer screening programs.

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.