BCAL Diagnostics (ASX:BDX) Validates BREASTESTplus 2 Ahead of Planned November Launch

Aditi Sarkar

30 September 2026 03:03 PM AEST

BCAL Diagnostics (ASX:BDX) Validates BREASTESTplus 2 Ahead of Planned November Launch

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Key Highlights

BCAL reports 80.3% sensitivity and 48.5% specificity in its validation study.
The test covers women aged 30 and over across all breast densities.
BCAL plans a November 2026 commercial launch across three Australian Capital cities.
The company continues accreditation and commercialisation work ahead of the planned rollout.

BCAL Diagnostics Limited (ASX:BDX) is moving its updated breast cancer blood test toward commercial launch after reporting clinical validation results for BREASTESTplus 2. The company plans to introduce the test in Sydney, Melbourne and Brisbane in November 2026 before pursuing a national rollout.

Validation Sets the Commercial Stage

BREASTESTplus 2 uses an enhanced lipid biomarker panel for detecting early-stage breast cancer, covering Stage 0, Stage 1 and Stage 2. BCAL reported sensitivity of 80.3% and specificity of 48.5%. Of the breast cancers detected in the validation study, 61.9% were Stage 0 or Stage 1. The announcement did not state the number of participants or cases included in the study.

A Broader Population Comes Into View

The company states that the test has been validated for women aged 30 years and over across all breast densities. BCAL is positioning the blood test as an additional screening option, while making clear that BREASTESTplus 2 is not a diagnosis and is not intended to diagnose breast cancer as a standalone test. Further assessment is required to confirm a result.

Accreditation Work Continues Before Launch

BCAL is advancing accreditation and commercialisation activities ahead of the planned November launch. The announcement does not specify Therapeutic Goods Administration approval, Australian Register of Therapeutic Goods listing, pricing or Revenue expectations. The company plans to launch initially in Sydney, Melbourne and Brisbane before a broader national rollout.

October Event Leads Into November

Ahead of the planned launch, BCAL will attend the Australasian International Breast Congress in Brisbane from 8 to 10 October 2026. The company plans to use the event to build stakeholder awareness while its accreditation and commercialisation work continues.

Launch Preparations Move Forward

BCAL now moves toward its planned November 2026 launch in three cities, with accreditation, commercialisation activity and subsequent national rollout forming the next stages.

FAQs

Q: What sensitivity did BREASTESTplus 2 report?

A: The company reported sensitivity of 80.3%.

Q: What specificity did the test report?

A: BCAL reported specificity of 48.5%.

Q: Who has the test been validated for?

A: BCAL states that BREASTESTplus 2 has been validated for women aged 30 years and over across all breast densities.

Q: When does BCAL plan to launch BREASTESTplus 2?

A: The company plans a commercial launch in Sydney, Melbourne and Brisbane in November 2026.

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