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. The market size is limited by the technology in place (which is only effective with women aged 50-74 years) and the low level of compliance (due to fear of X-Rays and need to visit 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 will be made up of false negatives, false positives and indeterminate results. 

In comparison to imaging technologies, BCAL test will be accessible to all women regardless of age and location. This is particularly advantageous for women between the age of 20 to 40 years who have no other effective screening method. As it is a blood-based test, BCAL is less invasive, with no exposure to x-rays, and fits in with standard laboratory blood collection and laboratory processing. BCAL will be a more cost effective and efficient business model than current imaging technologies – changing the model from multiple, high cost screening centers to a centralized cost effective laboratory process. This will reduce healthcare costs, increase user compliance and clinical outcomes.

Published studies show that there is 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 been established.

BCAL Diagnostics' hypothesis is that the breast tumour releases lipids into the bloodstream which are subtlety changing the lipid profile of the patients blood. An 80-patient study found that there were some specific lipids, which 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 controls.

BCAL Diagnostics is working to develop this into a novel technology called the BCAL test (Breast Cancer Associated Lipids 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 has the ability to revolutionise the breast cancer diagnostic industry

 

Key BCAL Test Outcomes

Early detection potential with impressive AUC


BCAL 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, BCAL approach can be a competitive diagnostic

 

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