Australian healthcare company BCAL Diagnostics is developing the BREASTEST Monitor blood test intended to assist in evaluating women for local breast cancer recurrence after treatment.
The company stated that local recurrence in the breast or lymph nodes can occur in up to 15% of patients and may arise at any time after initial therapy, which can indicate treatment failure and raise the risk of cancer spreading to distant sites.
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According to BCAL, early detection of local recurrence is linked to improved patient outcomes and the possibility of curative intervention.
In a study involving women aged 50 and above with a previous diagnosis of breast cancer, BREASTEST Monitor demonstrated a sensitivity of 91%, correctly identifying 20 out of 23 confirmed cases of local recurrence, with a negative predictive value of 95%.
The test development process utilised more than 450 samples, and the algorithm was applied to a separate set of 100 samples, comprising 23 confirmed recurrences and 77 controls who had no evidence of recurrence on imaging.
The held-out samples were not used during the algorithm’s training and were designed to optimise the test’s performance across different age groups after breast cancer treatment.
BCAL stated that existing post-treatment surveillance relies mainly on imaging methods such as mammography, ultrasound or magnetic resonance imaging (MRI), which are described as time-consuming and costly.
It also noted that mammography may fail to detect 25%–32% of recurrences, particularly in women with dense breast tissue or changes due to prior treatment.
The company aims to introduce BREASTEST Monitor as an adjunct to imaging, with further development targeted at making it suitable for standalone use.
Additional clinical validation studies are planned before commercial launch, and the company is seeking further participants, including women under 50 who have previously undergone breast cancer treatment.
BCAL Diagnostics CEO Anne-Louise Arnett said: “BREASTEST Monitor is an important clinical development milestone for BCAL and extends our blood-based diagnostics platform into one of the most significant areas of unmet need in breast cancer care. The team will now work through the validation processes to advance the test.”
BCAL Diagnostics also launched BREASTESTplus, a blood test used with mammography to evaluate breast disease in women with dense breasts and holds an exclusive licence with ClearNote Health for the distribution of certain blood tests in Australia and New Zealand.
