BCAL Diagnostics Limited (ASX: BDX) (“BCAL” or “the Company”), an Australian and US-based biotechnology company pioneering non-invasive breast cancer diagnostics, is pleased to announce the commercial launch of BREASTEST plus™. This first-in-class blood test is available from Thursday, 27 March 2025 and will be used alongside standard-of-care imaging in breast cancer screening and diagnostics. The Company is pleased that this launch has been achieved within the previously announced target timeframe of having the test commercially available in Australia by the end of 1Q CY2025.

Highlights:

• BREATEST plus™ and first sales revenue this week
• Additional patents granted

BREASTEST plus™ has been validated to meet the challenge of high breast density, which affects approximately 50% of Australian women participating in breast cancer screening programs. High breast density masks abnormal lesions on mammography, in many cases making it difficult to diagnose. In line with the Company’s stated market entry strategy, BREASTEST plus™ will provide clinicians with a new, additional tool to help overcome this longstanding challenge.

Marking a New Era in Breast Cancer Diagnostics with Focused Launch

BREASTEST plus™ will be available at Sydney Breast Clinic from Thursday this week, with a planned roll out to additional select clinical sites, initially in Sydney and Melbourne, to follow. BCAL is focused on ensuring a systematic national rollout, working closely with our clinical partners, to ensure Australian women will have access to BREASTEST plus™.

BCAL collaborated with its Clinical Advisory Board of eminent Australian breast surgeons, radiologists and physicians to develop BREASTEST plus™, ensuring it meets the needs of women with high breast density who are often the most challenging to diagnose via traditional imaging.

Chief Executive Officer, Shane Ryan commented:“The commercial launch of BREASTEST plus™ is an incredible milestone for BCAL and for the future of breast cancer screening. This innovative blood test has the potential to significantly improve the early detection pathway of breast cancer, and places BCAL at the forefront of blood-based tests for the detection of breast cancer.

We look forward to rolling out BREASTEST plus™ nationally and ensuring widespread adoption and long-term success, supporting women and clinicians with cutting-edge screening tools.”

Breast Surgeon and Head of BCAL’s Clinic Advisory Board, Dr David Speakman commented:“Anything we can do to detect breast cancer earlier, to rule it in or out, is a vital step forward for women and saving more lives.

“This simple blood test can aid clinicians and their patients, in assessing for any sign of breast cancer which is a step change from relying on breast imaging alone.”

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