BCAL Secures Ethics Approval for 24,000-Patient BREASTESTplus Registry

• National ethics approval granted for BREASTEST Registry involving up to 24,000 women
• Registry to collect real-world data on BREASTESTplus use in breast cancer diagnosis
• Focus on women with dense breast tissue, historically underserved by screening
• Data to support clinical utility, doctor decision making, and reimbursement efforts
• Longitudinal tracking over 24–36 months with feedback from participating clinicians

A New Chapter in Breast Cancer Diagnostics

BCAL Diagnostics Limited (ASX, BDX), an Australian pioneer in early cancer detection, has taken a significant step forward by receiving national ethics approval to establish The BREASTEST Registry. This ambitious study will involve up to 24,000 women undergoing the BREASTESTplus blood test as part of their clinical care, marking one of the largest real-world evaluations of a diagnostic tool for breast cancer in Australia.

The BREASTESTplus test is designed to complement mammography, particularly for women with dense breast tissue, a group that has historically faced challenges with traditional screening methods. By offering a non-invasive blood test, BCAL aims to improve diagnostic accuracy and patient outcomes in this underserved population.

Driving Evidence-Based Adoption

The registry will serve as a vital catalyst for broader clinical adoption by generating robust, longitudinal data on how BREASTESTplus influences diagnostic pathways. Over a 24 to 36-month period, the study will track clinical outcomes, including the impact on follow-up imaging and biopsy decisions. This real-world evidence is expected to underpin peer-reviewed publications that will guide best practices and inform reimbursement decisions within the Australian healthcare system.

Dr David Speakman, a breast surgeon involved in the initiative, emphasised the importance of this registry, "By studying BREASTESTplus in everyday diagnostic environments, we can more accurately assess its impact on patient pathways and ensure that women receive the most informed, evidence-based care." Such data is crucial for clinicians who rely on longitudinal studies to refine treatment protocols and improve patient management.

Strategic Implications for BCAL

BCAL’s CEO Shane Ryan highlighted the strategic value of the registry, noting that it will accelerate doctor adoption while providing the evidence base needed to support reimbursement. This dual focus addresses two critical barriers to market penetration, clinician confidence and payer acceptance. The registry’s findings could therefore play a pivotal role in expanding the test’s reach and ensuring it becomes a standard part of breast cancer diagnostic workflows.

Beyond Australia, BCAL holds exclusive licenses for other cancer diagnostic tests in the region, positioning the company as a growing force in precision diagnostics. The success of the BREASTEST Registry could set a precedent for similar initiatives, reinforcing BCAL’s commitment to innovation and patient-centred care.

Looking Ahead

While the timeline for data publication and reimbursement outcomes remains to be seen, the establishment of this registry marks a critical milestone. It signals BCAL’s confidence in BREASTESTplus and its potential to transform breast cancer diagnostics for women with dense breast tissue. Investors and clinicians alike will be watching closely as the registry progresses and its findings emerge.

Bottom Line?

BCAL’s BREASTEST Registry sets the stage for broader clinical adoption and reimbursement, but the real test lies in the data to come.

Questions in the middle?

• How quickly will the BREASTEST Registry data translate into reimbursement approvals?
• What impact will the registry findings have on clinical guidelines for dense breast tissue screening?
• Could BCAL leverage this registry model to accelerate adoption of its other cancer diagnostic tests?