Ann: Publication in Peer-Reviewed Journal, page-2

ASX Announcement
29 October 2024
BCAL Diagnostics announces publication in peer-reviewed
journal describing the discovery of the technology that
underpins BREASTEST®
Breast cancer screening and diagnostic company BCAL Diagnostics Limited (ASX:BDX, ‘BCAL’ or the
‘Company’) is pleased to announce that an original research article by BCAL has been published today
in the International Journal of Molecular Sciences.
The article describes the methodology and results from early discovery work that forms the basis of the
technology that underpins BCAL’s novel blood test for the detection of early-stage breast cancer,
BREASTEST®. The article is titled “Discovery of Plasma Lipids as Potential Biomarkers Distinguishing
Breast Cancer Patients from Healthy Controls”. The advanced online publication can be found at the
following LINK https://www.mdpi.com/1422-0067/25/21/11559.
Director of Clinical Research at BCAL and corresponding author, Simon Preston commented: “This
publication is an important milestone for the company. BCAL will be the first company to launch a cancer
detection test using a proprietary panel of lipids and machine-learning developed diagnostic algorithm.
Peer-reviewed publications are a crucial step to gaining academic and commercial validation of new
technologies such as ours. A number of publications that illustrate the methodical and step-wise
development of BREASTEST® are in process. It is exciting to see the first of these publications now in
press.”
Chief Executive Officer, Shane Ryan commented: “Peer-reviewed publications are a crucial aspect of
developing novel technologies like BREASTEST®. The publication provides us with critical support and a
strong foundation with which to move forward with the commercialisation of BREASTEST®. Today’s
publication mark’s BCAL’s first peer publication and a major milestone for BCAL. Several additional peerreviewed publications are planned for submission by the end of FY 2025 to support market access
strategies and global regulatory submissions”.
This announcement has been approved for release by the Board of BCAL Diagnostics Limited.
• Publication in the highly regarded International Journal of Molecular Sciences
• The article concludes that:
o Lipids extracted from blood-plasma can be used as target analytes in the
development of an assay to detect early-stage breast cancer
o A 20-lipid panel generated an AUC of 0.95, sensitivity of 0.91 and specificity of
0.79
• Detection of breast cancer at the early-stage supports BCAL’s intended use of
BREASTEST® in a screening population
• Peer-reviewed journal publications are an important part of BCAL’s commercialisation
and regulatory strategy