Researchers from the University of Louisville Research Foundation, Inc (ULRF) were able to show that breast cancer patient samples contain significantly different lipid profiles from those of both healthy volunteers and lung cancer patients; using a defined methodology. In 2011 ULRF filed a patent application using this data. Working independently in Sydney, BCAL’s science team observed a similar trend in their own research, and as a result the Company decided in 2013 to license the technology the subject of a patent application from ULRF.
While BCAL’s first objective is to secure TGA approval for use of a test based on this information used alongside mammography, the Company’s data and clinical trials are designed to facilitate sequential market entry points. The purpose of the Company has been, since inception, to achieve a sequential series of claims or uses for its test as follows, each of which depends on confirmatory data from successful clinical trials of BCAL’s technology, as:
(1) a screening test for breast cancer alongside mammography;
(2) a monitoring tool for breast cancer patients who have been given the “all clear” following treatment; and
(3) monitoring and screening for women who have the BRCA gene mutation, or are otherwise at high risk of developing breast cancer.
Ultimately, the clinical data and clinical trials will be utilised and assessed for their clinical utility by leading global key opinion leaders in the breast cancer diagnostic and treatment field. Successive regulatory approvals and marketing of the BCAL test for a widening range of indications will move BCAL towards its end goal of introducing a breast cancer screening blood test for every woman, everywhere.
It is anticipated that BDX will list on the ASX during July 2021.