Latest Diagnostics News

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.

4DMedical has renewed its three-year contract with the University of Michigan Medical Center, reinforcing its foothold in US respiratory imaging. Alongside, a pivotal clinical study validates its technology’s ability to detect early lung disease, while a substantial Australian grant boosts its AI research.

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

Clarity Pharmaceuticals has successfully completed recruitment for its pivotal Co-PSMA Phase II trial, testing its novel Cu-SAR-bisPSMA diagnostic against the current standard in detecting prostate cancer recurrence. This milestone advances their mission to improve early detection and treatment outcomes for men with low PSA levels.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

Pacific Edge Limited (ASX – PEB) has announced a securities purchase plan (SPP) aiming to raise up to NZD 5 million, contingent on shareholder approval of a prior NZD 16 million placement. The move is designed to bolster working capital amid ongoing growth initiatives.

Lumos Diagnostics Holdings Limited has had its ASX trading suspension lifted following news of a strategic material agreement, signaling potential growth ahead.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

Lumos Diagnostics has voluntarily suspended its ASX trading pending a market announcement about strategic agreements, signaling potential shifts in its business trajectory.

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.