BCAL Diagnostics Develops Blood Test for Breast Cancer Recurrence Monitoring

BCAL Diagnostics (ASX: BDX) has developed BREASTEST Monitor, a new blood test designed to help evaluate women for local recurrence of breast cancer after treatment.

The test has been developed as a simple, non-invasive way to rule out the presence of local recurrence in the breast, armpit, or lymph nodes.

Preliminary findings in women aged 50 years and above showed BREASTEST Monitor correctly identified 20 of 23 confirmed local recurrence cases, with sensitivity of 91% and Negative Predictive Value (NPV) of 95%.

The program extends BCAL’s blood-based diagnostics platform into post-treatment surveillance, where recurrence monitoring remains a major clinical challenge for patients and clinicians.

Post-Treatment Need

Local recurrence can occur in up to approximately 15% of women after breast cancer treatment and may emerge many years after the original diagnosis.

Early detection remains important because local recurrence is considered curable when identified promptly and treated early.

Post-treatment monitoring currently relies largely on imaging such as mammography, ultrasound or magnetic resonance imaging (MRI), which can be time consuming, costly and less effective in some patients.

Mammography can miss up to 25% to 32% of recurrences, with higher failure rates in women with dense breast tissue or post-treatment scarring and tissue thickening.

Algorithm Development

BCAL developed the BREASTEST Monitor algorithm using more than 450 samples before applying it to a held-out test set of 100 samples.

The held-out set included 23 confirmed local cancer cases and 77 imaging-negative women who had previously received breast cancer treatment.

Those samples were not used to train the algorithm and were instead used to optimise its ability to detect early-stage local recurrence in treated breast cancer patients across various age groups.

The test is initially being positioned as an adjunct to imaging, with a longer-term plan to develop BREASTEST Monitor as a standalone surveillance tool.

Older Women Targeted

BCAL is targeting women aged 50 years and older who have been treated for breast cancer or are undergoing treatment.

More than 4 million breast cancer survivors in the US and more than 200,000 in Australia require ongoing surveillance, with the global breast cancer surveillance and monitoring market is projected to reach $4.5 billion by 2030.

BCAL is seeking additional breast cancer patients for further validation studies, including women under 50 years of age who have undergone treatment.

Additional clinical validation studies must be completed before commercial launch, and BCAL has already launched BREASTESTplus as a rule-out test for clinical evaluation of breast disease in women with dense breasts, used in conjunction with mammography.

The company also holds an exclusive licence with US-based ClearNote Health for the sale and distribution of Avantect pancreatic, ovarian, and multi-cancer blood tests in Australia and New Zealand.

Important Clinical Milestone

Chief executive officer Anne-Louise Arnett said the new test marked an important clinical development milestone for BCAL.

“BREASTEST Monitor […] extends our blood-based diagnostics platform into one of the most significant areas of unmet need in breast cancer care.”

Executive manager clinical affairs breast cancer Shane Ryan said recurrence anxiety could remain a significant burden after treatment.

“BREASTEST Monitor is being developed to give women and their clinicians an easier, faster and non-invasive way to help evaluate the risk of local recurrence,” he said.

“This is about supporting women after treatment, when reassurance and ongoing care are critically important.”