Latest Cancer Diagnostics News

Rhythm Biosciences has moved ColoSTAT and geneType into commercial use, recording its first sales during FY2026. But with sales revenue of just $85,339, a $5.93 million loss and an auditor-flagged going-concern uncertainty, the next phase will be judged on cash generation and repeat adoption.

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.

Rhythm Biosciences has completed the first phase of transferring its ColoSTAT blood test to an independent NHS laboratory in England. The milestone supports its international laboratory-partnership strategy, but clinical validation and NHS adoption remain ahead.

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.

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.

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

BCAL Diagnostics has strengthened its leadership, advanced breast cancer detection tests, and secured key funding and strategic investments to underpin its FY2027 growth plans.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.

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.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.