BCAL Diagnostics Develops Blood Test for Breast Cancer Recurrence Monitoring
BCAL Diagnostics has developed BREASTEST Monitor, a blood test designed to evaluate women for local recurrence of breast cancer following treatment. The test demonstrated 91% sensitivity and 95% Negative Predictive Value (NPV) in preliminary findings among women aged 50 and above, correctly identifying 20 of 23 confirmed local recurrence cases.
Local recurrence affects up to 15% of treated breast cancer patients and can occur years after initial treatment. BREASTEST Monitor builds on BCAL’s existing diagnostics capabilities, expanding the company’s product pipeline beyond initial screening into the post-treatment surveillance market.
What is local breast cancer recurrence and why does it matter?
Local recurrence refers to cancer returning in the breast or armpit lymph nodes after treatment. This occurs in approximately 15% of breast cancer patients and can emerge at any point during the years following initial treatment, signalling potential treatment failure and substantially elevating the risk of distant metastatic spread.
Early detection of local recurrence is considered curable, with early treatment directly linked to improved patient outcomes. Current monitoring methods rely heavily on imaging technologies such as mammography, ultrasound, and MRI. Mammography misses 25–32% of recurrences, with higher failure rates in women with dense breast tissue or post-treatment scarring and tissue thickening.
BREASTEST Monitor is being developed as a “rule-out” test designed to identify women who do NOT have recurrence. This approach aims to reduce unnecessary procedures and alleviate anxiety for women undergoing ongoing surveillance.
The test addresses a significant gap in post-treatment care where no simple blood-based assessment currently exists for this patient group.
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Preliminary study results and validation pathway
BCAL’s initial study focused on women aged 50 and above with known previous breast cancer. The company used more than 450 samples to develop the test algorithm, which was then applied to a held-out test set of 100 samples.
The held-out test set comprised 23 confirmed local cancers and 77 imaging-negative previously treated women as controls. These samples were not used in training the algorithm but were used to optimise the model’s ability to detect early stage local recurrence across various age groups.
The test correctly identified 20 of the 23 confirmed local recurrences, achieving 91% sensitivity and 95% NPV. BCAL is now recruiting breast cancer patients, including those under 50 years of age, to expand the validation cohort. Additional clinical validation studies are required before commercial launch.
Anne-Louise Arnett, Chief Executive Officer
“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.”
The validation pathway signals that commercial launch is not immediate, but the preliminary data provides proof-of-concept for the development trajectory.
Market opportunity in breast cancer surveillance
The target population for BREASTEST Monitor is substantial. More than 4 million breast cancer survivors in the United States and 200,000+ in Australia require ongoing surveillance. The global breast cancer surveillance and monitoring market is projected to reach $4.5 billion by 2030.
No simple blood-based test currently exists to assess local recurrence in this patient group. BCAL’s commercial strategy positions BREASTEST Monitor to enter the market as an adjunct to imaging, with a longer-term plan to develop the test as a standalone surveillance option.
| Metric | Value |
|---|---|
| US breast cancer survivors | 4 million+ |
| Australian breast cancer survivors | 200,000+ |
| Local recurrence rate | Up to 15% |
| Mammography miss rate | 25–32% |
| Global surveillance market (2030) | $4.5 billion |
The large survivor population requiring ongoing monitoring represents a recurring revenue opportunity distinct from one-time diagnostic testing. The clinical need for more accurate surveillance methods creates both a market gap and a potential pathway for reimbursement.
The GP referral infrastructure BCAL has built for its existing cancer tests, with referral forms embedded into software covering approximately 97% of Australian general practitioners, provides a ready-made clinical access channel that a commercially launched BREASTEST Monitor could also leverage.
Addressing the emotional burden of post-treatment care
The test development addresses documented quality-of-life concerns for breast cancer survivors. Post-treatment monitoring carries significant psychological weight alongside its clinical purpose.
Shane Ryan, Executive Manager Clinical Affairs Breast Cancer
“For women who have been treated for breast cancer, fear of recurrence can remain a major burden. 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. This is about supporting women after treatment, when reassurance, and ongoing care are critically important.”
The non-invasive blood test format offers a faster evaluation method compared to imaging-based surveillance. The test’s design as a rule-out tool aims to provide reassurance to women when results are negative, potentially reducing unnecessary follow-up procedures.
The patient-centric positioning supports both clinical adoption and potential reimbursement pathways by addressing documented concerns in post-treatment breast cancer care.
BCAL’s expanding diagnostics platform
BCAL’s existing product, BREASTESTplus, is a rule-out test designed for clinical evaluation of breast disease in women with dense breasts. The test is used in conjunction with mammography to improve screening and diagnostic outcomes.
The company holds an exclusive licence with ClearNote Health Inc., a US-based precision diagnostics company, for the sale and distribution of Avantect Pancreatic, Avantect Ovarian, and Avantect multi-cancer blood tests in Australia and New Zealand.
The BreastestPlus validation pathway into the US market follows a similar logic, with BCAL having signed an agreement with Sonic Healthcare USA to pursue the Laboratory Developed Test route, which bypasses FDA pre-market approval and represents the fastest available commercial entry point.
BREASTEST Monitor represents a platform extension that leverages BCAL’s existing blood-based diagnostic capabilities. The development demonstrates the company’s ability to apply its technology across multiple clinical applications, addressing both pre-treatment screening and post-treatment surveillance.
This expansion reduces single-product risk by creating a broader diagnostic portfolio targeting different stages of the breast cancer care pathway.
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Next steps for BCAL
The company has outlined a clear development pathway for BREASTEST Monitor. The validation process requires additional clinical studies before the test can launch commercially.
BCAL is expanding patient recruitment to include women under 50 years of age, broadening the validation cohort beyond the initial study population. The commercial strategy targets an initial launch as an imaging adjunct, with longer-term development toward standalone surveillance test positioning.
The progression pathway includes:
- Complete additional clinical validation studies
- Expand patient cohort to include women under 50
- Progress toward commercial launch as imaging adjunct
- Develop pathway toward standalone surveillance test positioning
These milestones provide a framework for tracking BREASTEST Monitor’s development as BCAL works through validation processes required for market entry.
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