Latest Cancer Detection News

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.

BCAL Diagnostics has secured national ethics approval to establish a large-scale registry tracking the clinical impact of its BREASTESTplus blood test for breast cancer diagnosis, aiming to enhance doctor adoption and reimbursement prospects.

Imagion Biosystems is set to submit its Investigational New Drug application for the MagSense® HER2 breast cancer imaging agent in December 2025, paving the way for a Phase 2 clinical trial in early 2026. Collaboration with Wayne State University has refined the trial design, promising improved patient safety and diagnostic precision.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

BCAL Diagnostics is preparing to launch its Avantect® pancreatic and ovarian cancer blood tests in Australia by January 2026, following key regulatory approvals and promising clinical data. The company also broadens the reach of its BREASTESTplus™ breast cancer test, targeting a larger segment of women with dense breast tissue.

Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.

Cleo Diagnostics has identified a significantly larger U.S. patient population for its pre-surgical ovarian cancer test, expanding its commercial opportunity ahead of next year’s market entry.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.

Cleo Diagnostics has secured positive FDA feedback and nearly 1,600 biobank samples, accelerating its ovarian cancer blood test development ahead of a planned 2026 U.S. market entry.

BCAL Diagnostics has secured key partnerships and a $10 million convertible note facility to expand its cancer detection tests across Australia and New Zealand, marking steady commercial progress in Q3 2025.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.