The BCAL Test
The current breast cancer screening market is dominated by imaging technologies such as mammograms and ultrasound and is one of the few screening markets with broad government funding in many jurisdictions. The market size is limited by the technology in place (which is effective with women aged 50-74 years, but less effective with younger age groups) and the low level of compliance (whether due to cultural or religious concerns, fear of x-rays, or the need to physically attend breast screening clinics). Although mammography has been shown be an effective screening tool, the accuracy of this technology has its limitations and consequently 30% of mammography screening results can provide false negatives, false positives, and indeterminate results.
Published studies have shown an association between breast cancer and some specific lipids. This change is detectable directly in breast cancer tissue and cells. The role of these lipids in disease is still being fully understood but their value as metabolites of interest has already been established.
BCAL Diagnostics' hypothesis is that the breast tumour releases lipids into the bloodstream which are subtly change the lipid profile of a patient’s blood. An 80-patient study found some specific lipids that were changing due to the presence of the disease, and these were possible markers for breast cancer.
In parallel, but entirely independently, researchers in the US had carried out a similar study and found that some the same lipids were changing significantly between those with the disease compared to the controls.
BCAL Diagnostics is working to develop this into a novel technology called the (Breast Cancer Associated Lipids (BCAL) test). The BCAL test is a lipid biomarker blood test with the potential to be used for breast cancer prevention, screening, and monitoring. This technology looks to revolutionise the breast cancer diagnostic industry.
As it is a blood-based test, the BCAL test is less invasive, with no exposure to x-rays, and fits in with standard laboratory blood collection and laboratory processing. The BCAL test is also designed to be a more cost effective and efficient business model than current imaging technologies, changing the model from multiple, high-cost screening centres to a centralized cost-effective laboratory process. This approach seeks to reduce healthcare costs, increase user compliance and clinical outcomes.
Key BCAL Test Outcomes
Early detection potential with impressive AUC
BCAL Diagnostics approach separates control from IDC Stage 1 and Stage 2 using 12 candidate markers and 2 clinical variables with 85% accuracy and 91% sensitivity (Table) and impressive AUC
Once validated, the BCAL Diagnostics approach can be a competitive diagnostic