BCAL Diagnostics (ASX:BDX) says it has met a major milestone in its development pathway to launching a blood test for breast cancer.
BCAL said its test is based on changes in the lipid composition that occur in the blood of women who develop breast cancer. It said the sum of the changes that occur in the blood of patients with breast cancer defines a breast cancer signature that the BCAL BREASTEST can detect.
BCAL has now identified and confirmed the key 20 lipids that make up this signature. It said these 20 lipids provide the basis for the proprietary BREASTEST that is planned to be launched in 2024.
To identify the signature, BCAL has compared lipid profiles in blood samples from more than 2,000 biopsy-confirmed breast cancer patients and healthy control subjects. The spectrum of lipids in human blood plasma is a complex inventory of more than 1,000 distinct types. The different lipids in blood and tissue play essential roles in cell structure, energy utilisation, and messaging between cells.
The transformation of cells from normal to cancer is driven in part, and accompanied by, changes in the production and metabolism of some classes of lipids, and it is these changes that constitute the BREASTESTT lipid signature.
BCAL executive chair, Jayne Shaw, said, “The confirmation of the identity and locking down of the lipids involved with the breast cancer signature is a crucial step towards providing the BCAL BREASTEST to the clinical community involved with the screening, care and management of breast cancer patients. Next steps involve the clinical validation of the test performance."
CEO Dr John Hurrell added, “This step is the culmination of more than 10 years dedicated efforts by BCAL Founders, Jayne Shaw and Hon. Ron Phillips AO, the research team at BCAL and the support from our many clinical and scientific advisors. With the identification of the lipids constituting the breast cancer signature, the completion of setting up and equipping our development and clinical services laboratory where commercial testing will be carried out, and supported by the additional capital raised recently, we are now poised to complete the development of the BREASTEST and have it available to the clinical community next year.”