Breast cancer screening blood test heads to commercial launch

Diagnostics & MedTech News: An Australian diagnostics company focused on early breast cancer detection, has entered into a commercial license agreement with one of the nation’s leading multi-disciplinary breast screening clinics, Sydney Breast Clinic. This collaboration represents a key milestone for BCAL Diagnostics as it moves closer to commercialising its breast cancer blood test, Breastest.

Sydney Breast Clinic has played an integral role in BCAL’s clinical studies over the past six years, providing blood samples to help in the development and validation of the Breastest.

Shane Ryan, CEO of BCAL Diagnostics, stated “We are proud to continue our longstanding collaboration with Sydney Breast Clinic, one of the leading private breast cancer clinics in Australia. This licensing agreement means that Sydney Breast Clinic will be the first site in Australia to offer our breast test to women when it becomes clinically available.”

While mammograms remain the standard screening tool for breast cancer, they are far from perfect. In 2023, 2.1 million mammograms were performed in Australia, yet 1.5 million eligible women opted out. This amounts to 41% of eligible women not being screened, often due to discomfort or cultural barriers. Additionally, women under 40 are generally not eligible for government-funded mammograms unless they are deemed high-risk due to genetic factors.

The limitations of mammograms are also reflected in their accuracy, with sensitivity of 54.5% and specificity of 85.5%. These shortcomings result in missed tumours and unnecessary follow-up biopsies. By contrast, BCAL’s Breastest claims to offer 90% sensitivity and 85.5% specificity, making it a more reliable in detecting tumours.

Magnetic resonance imaging (MRI) scans, while more accurate at 94.6% sensitivity and 74.2% specificity, are costly, ranging between $900 and $1,200 per scan, and are typically reserved for the most vulnerable patients.

BCAL aims to build on its clinical validation evidence and is targeting a soft launch of the blood test later this year. Meanwhile, the company’s laboratory is also on track to complete its NATA audit and accreditation in the coming weeks.

Professor Mary Rickard, Medical Director of Sydney Breast Clinic, said “This collaboration presents a remarkable opportunity to be at the forefront of breast cancer detection and to partner with BCAL in their mission to improve patient outcomes. We are excited to contribute to the validation and commercialisation of this promising technology.”

BCAL Diagnostics initially plans to roll out the test across New South Wales and Victoria, including at Sydney Breast Clinic, Westmead and Royal Prince Alfred hospitals in Sydney, and Monash Medical Centre in Melbourne.

Priced at approximately $300 out-of-pocket, the test will complement standard of care mammography, offering a new blood test in early breast cancer detection.

Interestingly, Jayne Shaw, Executive Chair and Founder of BCAL, and former New South Wales Liberal Party Health Minister Ron Phillips – who had previously invested in the Sydney Breast Clinic before its sale to Healthscope – were involved in acquiring intellectual property for the blood-based test. Shaw recused herself from the negotiation and settlement of this agreement with the Sydney Breast Clinic.

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