Latest Ovarian Cancer News

Cleo Diagnostics has begun developing a multi-biomarker blood test for ovarian cancer screening in asymptomatic women, targeting a stated $150 billion global market. The prototype program will run alongside the company’s pre-surgical test, with initial proof-of-concept data expected early next quarter.

Imagion Biosystems has signed nanoComposix to resume GMP-aligned manufacturing of the MagSense nanoparticle core, a move designed to support its FDA-cleared HER2 breast cancer programme without the fixed cost of an in-house facility. The agreement improves manufacturing readiness, but its value, duration and production commitments remain undisclosed.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

BCAL Diagnostics has increased its shareholding in Genetic Signatures to nearly a fifth, aiming to leverage infectious disease technology to complement its cancer detection portfolio.

Amplia Therapeutics has teamed up with Eli Lilly to test its FAK inhibitor narmafotinib alongside Lilly’s KRAS G12C inhibitor olomorasib in advanced non-small cell lung cancer, marking a strategic expansion beyond pancreatic and ovarian cancers.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

Amplia Therapeutics reported encouraging mature data from its ACCENT trial, initiated a Phase 2b pancreatic cancer study, launched an ovarian cancer trial, and refreshed its board leadership while maintaining a solid cash balance of A$24 million.

INOVIQ Ltd has revealed significant sample quality problems in its EXO-OC ovarian cancer diagnostic study, prompting a technical review and a refined development approach while maintaining its dual commercialisation strategy.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

INOVIQ Limited hit a roadblock in expanding clinical validation of its EXO-OC™ ovarian cancer test due to unsuitable biobank samples, yet improved its diagnostic algorithm and progressed its CAR-exosome therapeutic program, maintaining a solid cash position of A$9.35 million.