Can BCAL’s New Cancer Tests Transform Early Detection or Face Adoption Hurdles?

A New Frontier in Early Cancer Detection

BCAL Diagnostics Limited (ASX, BDX) is poised to make a significant impact on cancer diagnostics in Australia with the upcoming launch of its Avantect® pancreatic and ovarian cancer blood tests. Set for January 2026, this launch follows a series of important regulatory and clinical milestones achieved by BCAL’s partner, ClearNote Health, including UK regulatory approval and participation in major international clinical trials.

The Avantect® tests leverage an advanced epigenomic platform designed to detect cancers at early, more treatable stages. This is particularly notable for pancreatic cancer, where early detection has historically been elusive. The pancreatic test demonstrated an impressive sensitivity of 82.6% and specificity of 97.5% in early-stage patients, addressing a critical gap in current diagnostic tools.

Expanding Clinical Reach with BREASTESTplus™

BCAL is also expanding the clinical application of its BREASTESTplus™ test, which complements mammography by serving as a 'rule-out' test for breast cancer in women with dense breast tissue. New clinical data now supports its use in women with both breast density classes C and D, effectively doubling the addressable market to cover approximately half of the women screened for breast disease. This expansion enhances BCAL’s position in breast cancer diagnostics and promises broader clinical adoption.

Commercial and Clinical Momentum

ClearNote’s global progress bolsters BCAL’s commercial outlook. The Avantect® platform’s inclusion in the US Vanguard Trial; a large federally supported multi-cancer early detection study; provides independent validation that could accelerate acceptance. Additionally, progress toward reimbursement agreements with major US insurers and a priority fast-track submission for the pancreatic test in the US highlight the commercial potential beyond Australia.

Locally, BCAL is collaborating with leading pancreatic surgeon Professor Jaswinder Samra to develop clinical pathways that integrate these tests into routine care. Professor Samra emphasizes the transformative potential of epigenomic blood testing to improve survival by detecting pancreatic cancer when it is still operable.

Telehealth and Accessibility

To enhance patient access, BCAL plans to launch a dedicated telehealth service in early 2026, connecting individuals with qualified clinicians for early cancer detection consultations. This initiative aligns with broader healthcare trends toward remote care and may facilitate earlier diagnosis and intervention.

With an estimated addressable market exceeding $250 million annually in Australia for the pancreatic test alone, BCAL’s integrated approach combining innovative diagnostics, clinical partnerships, and telehealth services positions it as a potential leader in early cancer detection.