BCAL Diagnostics (ASX:BDX) Completes Clinical Validation of BREASTESTplus 2 for All Breast Densities, November Launch on Track

Sonal Goyal

30 September 2026 12:39 PM AEST

BCAL Diagnostics (ASX:BDX) Completes Clinical Validation of BREASTESTplus 2 for All Breast Densities, November Launch on Track

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Key Highlights

• BREASTESTplus 2 achieved clinical validation for early-stage breast cancer detection across all breast densities for women aged 30 and above.

• The test demonstrated sensitivity of 80.3% and specificity of 48.5% for Stage 0 to Stage 2 breast cancer in the validation study.

• Commercial launch is planned for November 2026 across Sydney, Melbourne, and Brisbane, ahead of a national rollout.

• Of breast cancers detected in the validation study, 61.9% were Stage 0 or Stage 1, highlighting the test's early detection utility.

BCAL Diagnostics Limited (ASX:BDX), an Australian healthcare company focused on early cancer detection, announced on 30 September 2026 that it has completed the clinical validation of its next-generation BREASTESTplus 2 blood test. The validation covers detection of early-stage breast cancer — Stage 0 (DCIS), Stage 1, and Stage 2 — across all breast densities for women aged 30 and above, with a commercial launch planned for November 2026.

About BCAL Diagnostics

BCAL Diagnostics is a Sydney-headquartered healthcare company that develops and commercialises blood-based cancer diagnostics. Its original BREASTESTplus test was designed as a rule-out tool for clinical evaluation of breast disease in women with dense breasts. The company also holds an exclusive licence with ClearNote Health Inc. for the sale and distribution of Avantect pancreatic, ovarian, and multi-cancer blood tests in Australia and New Zealand.

Clinical Validation Results

The clinical validation study for BREASTESTplus 2 demonstrated a sensitivity of 80.3% and a specificity of 48.5% for the detection of early-stage breast cancer from Stage 0 to Stage 2. Among breast cancers identified in the validation study, 61.9% were classified as Stage 0 or Stage 1, indicating that the test's detection profile is weighted toward earlier-stage disease.

The test uses an enhanced lipid biomarker panel with stability and reproducibility characteristics supported through analytical validation. Independent bioinformatics validation was provided by OmniOmics.ai, which developed a multifactorial diagnostic algorithm integrating lipid biomarkers measured in plasma with clinical features.

The specificity result of 48.5% indicates that approximately half of women without the disease who take the test would receive an elevated result. BCAL has positioned BREASTESTplus 2 as a supplementary tool rather than a standalone diagnostic, noting that an elevated result warrants further investigation but does not constitute a diagnosis. The company emphasised that the test is designed to be used alongside other diagnostic pathways.

Expanded Patient Eligibility

The second-generation test broadens patient eligibility compared to the original BREASTESTplus, which was focused on women with dense breasts. BREASTESTplus 2 is validated for use across all breast densities for women aged 30 and above, significantly expanding the addressable population. Currently, approximately 48% of eligible Australian women are being evaluated regularly with mammography, leaving a portion of the population without routine screening coverage where a blood-based supplement could add informational value.

Commercial Launch and Rollout

BCAL is targeting a simultaneous launch of BREASTESTplus 2 in Sydney, Melbourne, and Brisbane in November 2026, ahead of a national rollout. The company will attend the 2nd Australasian International Breast Congress in Brisbane from 8–10 October 2026 to build awareness among key Stakeholders prior to launch. Referral pathways including Best Practice, Genie, and Medical Director will be updated to incorporate BREASTESTplus 2. The company's patient education platform at www.earlydetection.com.au will support access to telehealth and GP referrals.

Key Takeaways

BCAL Diagnostics has completed the clinical validation phase for BREASTESTplus 2, achieving coverage across all breast densities and an expanded patient population from age 30 upward. With sensitivity of 80.3% in the validation study and a November 2026 commercial launch confirmed across three major Australian cities, the company is entering its commercialisation phase. Investors and analysts will be watching the uptake trajectory once the test launches nationally.

FAQs

Q: What is BREASTESTplus 2?

A: BREASTESTplus 2 is a non-invasive blood test developed by BCAL Diagnostics for the detection of early-stage breast cancer (Stage 0 to Stage 2) across all breast densities, validated for women aged 30 and above.

Q: What were the clinical validation results for BREASTESTplus 2?

A: The test demonstrated sensitivity of 80.3% and specificity of 48.5% for early-stage breast cancer detection, with 61.9% of cancers detected in the study being Stage 0 or Stage 1.

Q: When and where will BREASTESTplus 2 be commercially launched?

A: The test is planned for launch in November 2026, commencing simultaneously in Sydney, Melbourne, and Brisbane before a national rollout.

Q: How does BREASTESTplus 2 differ from the original BREASTESTplus?

A: The second-generation test is validated for all breast densities rather than only dense breasts, and for women aged 30 and above rather than a narrower cohort, significantly expanding the addressable patient population.

Q: Is BREASTESTplus 2 a diagnostic tool on its own?

A: No. The test is designed to be used alongside existing diagnostic pathways such as mammography and imaging. A normal result supports reassurance, while an elevated result flags the need for further investigation, but it does not constitute a standalone breast cancer diagnosis.

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