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At BCAL Diagnostics, we believe that early diagnosis of breast cancer and early intervention will improve clinical outcomes for all women. BCAL Diagnostics has a dedicated team of individuals with an aim of delivering this test to all women, everywhere. Since forming in 2010, BCAL Diagnostics has been striving to address the issues surrounding the early detection and more accurate method of screening for breast cancer.
Whilst current imaging technologies are effective in screening for the disease, they have their limitations. Biomarkers for breast cancer would be ideal to overcome these issues, as they eliminate the need for imaging the breast. BCAL Diagnostics recognizes that there is a need for a more accurate screening test for women of all ages, which can detect the cancer at a cellular level and before metastasis.
Published studies shows 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, in collaboration with the US researchers completed a study reaffirming the results of previous studies carried out by both groups with preliminary indications of around 90% accuracy.
In late 2017, BCAL brought the science back to Australia and is now based at the Charles Perkins Centre in Sydney University and Sydney Knowledge Hub. Since 2018, BCAL analysed around 490 freshly collected Invasive Ductal Carcinoma (IDC) and matched control samples in 3 cohorts. We have focused on IDC as it forms 70-80% of all diagnosed invasive breast cancer cases, while collecting high quality fresh samples to include other breast cancer types. We have identified a panel of markers that can distinguish healthy from IDC at early Stages (Stage I & II), with sensitivity as high as 90%, often when mammogram may miss it.
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. Collectively to date, BCAL analysed over 735 human plasma samples in studies undertaken in the USA and Australia. We are in the process of validating the findings in larger cohorts and expanding to other breast cancer types. BCAL entered a clinical collaboration with RPA, Lifehouse and NSW BreastScreen to further validate the test in a real-world setting.
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