BCAL Diagnostics (ASX:BDX) has taken a significant step toward strengthening clinical confidence in its flagship breast cancer diagnostic, announcing national ethics approval for a large-scale registry that will track outcomes for up to 24,000 Australian women.
The new initiative, known as The BREASTEST Registry, will capture real-world evidence on how BREASTESTplus, a non-invasive blood test designed to support the evaluation of breast disease, particularly in women with dense breast tissue, is being used across routine clinical practice. Women receiving the test through participating sites will be invited to enrol, allowing BCAL to build an unprecedented dataset on its performance, utility and long-term clinical impact.
According to BCAL, the registry will follow participants for up to three years, assessing how the test influences diagnostic pathways, including decisions around follow-up imaging and biopsies. Clinicians will also report how BREASTESTplus affected their decision-making, offering a clearer picture of where the test adds value in everyday diagnostic environments.
Breast surgeon Dr David Speakman emphasised the significance of the registry for clinical adoption. “This registry will generate the kind of longitudinal data and peer-reviewed publications that clinicians rely on to guide best practice,” he said. “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.”
BCAL CEO Shane Ryan described the registry as both a scientific and strategic milestone. “The BREASTEST Registry will help accelerate doctor adoption while collecting real-world data to support future reimbursement,” he said. “This bold initiative reinforces BCAL’s commitment to equip medical professionals with the tools and evidence they need to optimise the use of BREASTESTplus for women with dense breast tissue.”
Dense breast tissue, present in roughly 40 per cent of women, can reduce the accuracy of traditional mammography, making supplementary diagnostic tools increasingly important. BCAL positions BREASTESTplus as a 'rule-out' test that can help clinicians better manage diagnostic uncertainty and streamline clinical pathways.