BCAL Diagnostics Limited (ASX: BDX), an Australian healthcare company pioneering diagnostics for early detection of cancer, has announced the development of BREASTEST Monitor. This new diagnostic blood test is designed to evaluate women for local recurrence of breast cancer following treatment, aiming to provide a simpler and easier method for post-treatment surveillance.
BREASTEST Monitor addresses a significant challenge in post-treatment breast cancer care, as disease recurrence in the breast or lymph nodes can occur in up to 15% of women. Early detection of local recurrence is crucial for improved patient outcomes. In its preliminary findings from a study in women aged 50 years and above, BREASTEST Monitor identified 20 of 23 confirmed local recurrence cases, demonstrating a sensitivity of 91% and a Negative Predictive Value (NPV) of 95%. The test algorithm was developed using over 450 samples and validated on a held-out test set.
This development targets a substantial unmet clinical need, particularly for women over 50 who have undergone breast cancer treatment. Current monitoring largely relies on time-consuming and costly imaging methods like mammography, which can miss a notable percentage of recurrences. While initially planned as an adjunct to imaging, BCAL intends for BREASTEST Monitor to eventually serve as a standalone surveillance test. Anne-Louise Arnett, Chief Executive Officer, stated that the test is an important clinical development milestone, extending BCAL’s diagnostics platform into a critical area of unmet need.
With the global breast cancer surveillance and monitoring market projected to reach $4.5 billion by 2030, BCAL Diagnostics is now seeking additional breast cancer patients, including those under 50, for further clinical validation studies ahead of commercial launch. Shane Ryan, Executive Manager Clinical Affairs Breast Cancer, highlighted that BREASTEST Monitor is being developed to offer women and their clinicians a non-invasive way to help evaluate recurrence risk, providing essential reassurance and ongoing care.
