BREASTESTplus 2 clinically validated across all breast densities ahead of November launch
BCAL Diagnostics Limited (ASX: BDX) has completed clinical validation of its next-generation BREASTESTplus 2 blood test for the detection of early-stage breast cancer across all breast densities, with a commercial launch planned for November 2026. The test is validated for women aged 30 years and over, broadening eligibility beyond the original BREASTESTplus, and will launch simultaneously in Sydney, Melbourne, and Brisbane ahead of a national rollout.
In the clinical validation study, BREASTESTplus 2 demonstrated sensitivity of 80.3% and specificity of 48.5% for the detection of early-stage breast cancer (Stage 0 [DCIS], Stage 1, and Stage 2). Of the breast cancers detected in the study, 61.9% were Stage 0 or Stage 1.
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Q&A: what is BREASTESTplus 2 and how does it work?
BREASTESTplus 2 is a non-invasive blood test that uses an enhanced lipid biomarker panel to give women and their doctors additional information about breast health. It is designed to sit alongside existing diagnostic pathways, not replace them.
A ‘Normal’ result provides reassurance. An ‘Elevated’ result signals that further investigation is warranted. It is not a standalone diagnosis; clinicians are expected to continue routine management and use the result as one additional data point within a broader clinical picture.
A substantial unmet need exists in Australia. Currently, approximately only 48% of eligible Australian women are being evaluated regularly with mammography. BREASTESTplus 2 is designed to reach women who are not regularly participating in mammographic screening, providing a simple, blood-based option that broadens access to breast health information.
Key product features include:
- Women aged 30 years+ across all breast densities
- Non-invasive, blood-based test
- Enhanced lipid biomarker panel with analytical validation supporting stability and reproducibility
- Developed and validated in Australia, with independent bioinformatics validation provided by OmniOmics.ai
Women receiving the test through participating sites will also be offered the opportunity to enrol in the BREASTEST Registry, which will build real-world evidence for BREASTESTplus 2 post-launch.
Expert voices back the clinical significance
Annie Arnett, CEO, BCAL Diagnostics
“BREASTESTplus 2 represents a significant advance in BCAL’s offering to the market, expanding patient eligibility and clinician access, and strengthens our position to deliver earlier breast-health assessment to a larger population of Australian women.”
Dr David Speakman, Breast and Melanoma Surgeon, Clinical Director of BreastScreen Victoria, and Director of Parkville Breast Service, provided clinical input during product development. He emphasised that the test adds a meaningful layer of information to a process that already involves multiple inputs.
“Breast cancer assessment is rarely about a single test. Clinicians build a picture using screening, imaging, clinical assessment and other information. Having an additional blood-based tool adds another important layer of information to support that process and help guide the next steps in a woman’s care. The significance of BREASTESTplus 2 is that it can be used across all breast densities, making it relevant to a broader group of women…”
Associate Professor Sanjay Warrier, Consultant Breast Surgeon at Chris O’Brien Lifehouse and Chief Surgeon at BreastScreen NSW, highlighted the relevance for women with dense breasts, a group for whom mammography alone can be insufficient.
“Every week I see women for whom a mammogram alone does not tell the whole story, particularly those with dense breasts. Used alongside imaging and clinical assessment, and across all breast densities, a simple blood test gives more women an additional piece of information about their breast health and, where warranted, an earlier prompt to look further…”
Commercial roadmap and investment thesis
November 2026 launch and national expansion
BCAL plans a simultaneous launch across Sydney, Melbourne, and Brisbane in November 2026, followed by a national rollout. Ahead of launch, the company will attend the 2nd Australasian International Breast Congress (AIBC) in Brisbane from 8–10 October 2026, to build awareness with key stakeholders.
Operational infrastructure is advancing. Existing referral pathways, including Best Practice, Genie, and Medical Director, will be updated to incorporate BREASTESTplus 2. Patient education and telehealth access will be supported through **www.earlydetection.com.au**.
Why this milestone matters for investors
Completion of clinical validation is the gating event before commercial revenue can begin. With that milestone now achieved, BCAL’s pathway to launch is de-risked on the clinical side, and the focus shifts to accreditation activities and commercial execution.
The addressable population is substantial. With approximately only 48% of eligible Australian women being evaluated regularly with mammography, BREASTESTplus 2 is positioned to reach a large, underserved group. BREASTESTplus 2 is one pillar of BCAL’s broader diagnostics strategy, which also includes an exclusive licence with ClearNote Health Inc. for the sale and distribution of Avantect Pancreatic, Avantect Ovarian, and Avantect multi-cancer blood tests in Australia and New Zealand.
Beyond early detection, BCAL is also developing the BREASTEST Monitor blood test for post-treatment surveillance, with preliminary findings reporting 91% sensitivity and 95% negative predictive value in a held-out test set of 100 samples.
| Feature | Detail |
|---|---|
| Eligible population | Women aged 30 years+ |
| Breast density coverage | All densities |
| Test type | Non-invasive blood test |
| Sensitivity / Specificity | 80.3% / 48.5% |
| Commercial launch | November 2026 — Sydney, Melbourne, Brisbane |
What comes next for BCAL
With clinical validation complete, several near-term catalysts will shape the company’s progress toward revenue generation:
- AIBC Brisbane (8–10 October 2026): Stakeholder engagement and pre-launch awareness building with key clinical audiences
- Accreditation activities: Advancing ahead of the planned November launch
- November 2026 commercial launch: Simultaneous rollout across Sydney, Melbourne, and Brisbane
- National rollout: To follow the initial three-city launch phase
- BREASTEST Registry: Data collection to begin post-launch, building real-world evidence for BREASTESTplus 2
For investors, the key signals to monitor will be the execution of the November launch and early indicators of commercial uptake across the three initial cities.
For investors exploring the broader financial picture and reimbursement pathway, our detailed coverage of BCAL’s FY2027 cancer detection strategy outlines the company’s cash position, committed funding, and the MSAC application that could eliminate patient out-of-pocket costs across its full test portfolio.
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