BCAL Diagnostics Unveils Blood Test Targeting Local Breast Cancer Recurrence
BCAL Diagnostics has developed BREASTEST Monitor, a blood test showing promising accuracy in detecting local breast cancer recurrence in women over 50, aiming to simplify post-treatment monitoring.
- BREASTEST Monitor detects local breast cancer recurrence with 91% sensitivity
- Test offers a non-invasive alternative to costly imaging methods
- Addresses surveillance needs for millions of breast cancer survivors
- Further clinical validation required before commercial launch
- Company seeks additional patients, including under 50 years
New Blood Test Targets Local Breast Cancer Recurrence
BCAL Diagnostics (ASX:BDX) has introduced BREASTEST Monitor, a blood test designed to detect local recurrence of breast cancer in women after treatment, marking a significant step in post-treatment surveillance. Preliminary results in women aged 50 and above indicate the test correctly identified 20 of 23 confirmed local recurrences, achieving a sensitivity of 91% and a negative predictive value (NPV) of 95%.
Addressing a Major Post-Treatment Challenge
Local recurrence occurs in up to 15% of breast cancer patients, often years after initial treatment, and signals a heightened risk of distant metastasis. Early detection is crucial as it is considered curable with timely intervention. Currently, surveillance relies heavily on imaging techniques such as mammography, ultrasound, or MRI, which can miss up to 32% of recurrences, especially in women with dense breast tissue or post-treatment scarring. BREASTEST Monitor offers a simpler, non-invasive blood-based alternative to these costly and time-consuming methods.
Robust Algorithm Development and Clinical Validation
The test’s algorithm was developed using over 450 samples and validated on a held-out set of 100 samples, including 23 confirmed recurrences and 77 controls with no imaging evidence of recurrence. This rigorous approach optimised the model’s ability to detect early-stage local recurrence across various age groups. BCAL is now seeking to expand its clinical validation studies to include breast cancer patients under 50 years of age ahead of commercial launch.
Market Potential and Strategic Positioning
With more than 4 million breast cancer survivors in the US and over 200,000 in Australia requiring ongoing surveillance, the global market for breast cancer monitoring is projected to reach US$4.5 billion by 2030. BREASTEST Monitor is positioned to enter this market as an adjunct tool, potentially easing the burden on imaging services and improving patient reassurance post-treatment.
Leadership Commentary on Clinical Impact
CEO Anne-Louise Arnett highlighted the test as a milestone extending BCAL’s blood-based diagnostics platform into a critical area of unmet need. Executive Manager Clinical Affairs Breast Cancer Shane Ryan emphasised the test’s potential to ease the psychological burden of recurrence fears by providing a faster, less invasive evaluation method for women and their clinicians.
Bottom Line?
BCAL’s BREASTEST Monitor shows early promise as a non-invasive tool for breast cancer recurrence surveillance, but its future hinges on successful clinical validation and market adoption.
Questions in the middle?
- How will BREASTEST Monitor perform in younger breast cancer survivors under 50?
- What regulatory hurdles remain before the test can be commercially launched?
- Can BCAL secure partnerships to scale adoption amid an evolving breast cancer monitoring landscape?
