Latest Diagnostics News

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.

Compumedics Limited has reported record sales orders and a return to profitability in FY25, setting the stage for robust growth in FY26 driven by US market traction and SaaS expansion.

Archer Materials advances its quantum computing and medical diagnostics technologies, extending key partnerships and forming a new advisory board while maintaining a strong cash position to fuel development.

Proteomics International’s subsidiary OxiDx has unveiled a pioneering test that detects muscle damage in thoroughbred racehorses, promising to transform recovery management in the racing industry. The test’s commercial launch is slated for the second half of 2025.