Latest Cancer Testing 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.

BCAL Diagnostics has begun introducing ClearNote Health’s Avantect Multi-Cancer blood test in Australia, starting with Sydney and Melbourne. The test reported 56.2% sensitivity and 98.4% specificity in a case-control validation study, but the company says a negative result does not rule out cancer.

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.

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.

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.

Rhythm Biosciences bolstered its financial position with a $5.2 million option underwriting while accelerating commercial adoption of its ColoSTAT® colorectal cancer test and advancing geneType™ partnerships internationally in Q4 FY26.

Pacific Edge edges closer to Medicare reimbursement for its bladder cancer tests while its Asia Pacific operations show rising test volumes and improved margins, signaling a path toward profitability.

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.