On behalf of the Directors of BCAL Diagnostics Limited (BCAL or the Company), it is my pleasure to invite you to
become a Shareholder.
BCAL is developing a new diagnostic approach for breast cancer using an in vitro diagnostic (IVD) blood test. BCAL’s initial
focus is to achieve Australian regulatory approval for its breast cancer diagnostic product to be employed alongside
traditional mammography. Using sequential trials, BCAL’s broader goal is to increase the range of situations in which
the product has been proven to be effective, leading towards the position where its use can improve international
breast cancer testing for every woman, everywhere.
Breast cancer is the most common cancer among women globally, with more than 2 million new cases of breast cancer
registered annually and approximately 627,000 resulting deaths. Improvements in medical and patient awareness
have emphasised the importance of early detection for effective treatment with a corresponding growth in global
demand for breast cancer diagnostics. The global market for these products was valued at just under US$5 billion
in 2019 and anticipated to expand at a compound annual growth rate of 7.3%, reaching US$8.7 billion by 2027.
There are two types of breast cancer evaluation: screening and diagnostic. Primary screening is by mammogram,
supported by diagnostic procedures including diagnostic mammography, ultrasonography and breast magnetic
resonance imaging (MRI). The final step in diagnostic evaluation is biopsy, whereby a sample of suspect breast tissue
is removed and evaluated for the presence of cancerous cells. While it is not uncommon for a mammogram to require
additional follow up, in part due to suspicious or unclear results, fewer than 10% of those called back for further testing
are found to have cancer. Where follow up testing is by away of biopsy, approximately 80% of lesions detected by
imaging are shown to be benign. As well as the high incidence of false positive results from mammography,
approximately 20% of breast cancers are estimated to be missed when mammography is the only screening method
employed, and these false negative results tend to be more common in women who have dense breast tissue.
By adding BCAL’s non-invasive test to mammography screening, the aim is to improve the accuracy of breast cancer
detection and reduce the rate of false positives and false negatives. BCAL’s approach looks for a “fingerprint” of lipid
biomarkers in blood which are characteristic of the presence of breast cancer, compared with the lipid profile in the
blood of healthy individuals.
The Company was established in Australia in 2010, and completed an initial series of in vitro (laboratory) studies
identifying alterations in specific lipids in the media of a breast cancer cell line, compared to the profile from a
non-cancerous cell line. From 2013 to 2017, BCAL undertook “proof of concept” studies with its USA and Australian
partners, to confirm that analysis of these lipids by mass spectrometry could potentially enable diagnosis of
In the next phase of its work, BCAL will undertake studies designed to demonstrate the value of its test in improving
diagnosis of breast cancer when it is used alongside mammography as an adjunct test, with its initial regulatory focus
on seeking approval from the Australian Therapeutic Goods Administration (TGA). The TGA approval sought will
be for priority review status for BCAL’s IVD test to be used as an adjunct to traditional mammogram screening.
BCAL’s present and future clinical studies are also designed to support future regulatory approval pathways.
Following successful domestic launch of the test as a diagnostic alongside traditional mammography BCAL will seek
further clinical data, both to support broader uses of the technology domestically and consider appropriate pathways
to markets in other jurisdictions.
BCAL collaborates closely with leading clinicians in Australia. Funds from the Offer will support the Company’s clinical
development program using statistically powered sample sizes to meet both clinical evidence and regulatory requirements.
BCAL is led by a small but highly capable and experienced management team, supported by a group of consultants with
substantial experience in clinical testing and development and commercialisation of diagnostic tests and related products.
Collectively, these technical experts, together with a Scientific Advisory Board and Board of Directors, bring extensive
scientific and commercial expertise.
The Company’s data and upcoming clinical studies are designed to facilitate multiple market entry pathways, which will
run in parallel. 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 as an adjunct to mammography;
(2) from further studies, a monitoring test for breast cancer patients who have been given the “all clear” following
(3) monitoring and screening test for women who have the BRCA gene mutation or are otherwise at high risk of
developing breast cancer.
Ultimately, BCAL’s ongoing 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. This will support the regulatory approval
process for the Company to deliver its end goal of introducing a breast cancer blood test suitable for use by every
During this process, BCAL will seek to assess potential applications of its technology for other cancers.
Under this Prospectus, BCAL is conducting its initial public offering of 32 million shares, at $0.25 per share to raise
$8 million (Offer), with the ability to accept Oversubscriptions of up to an additional $4 million. The Prospectus
details information about the Offer, BCAL’s operations, performance, financial position and key personnel, as well
as the broader industry sector in which the Company operates.
Proceeds raised will support the Company in:
(a) establishment of its mandatory Quality Management System (QMS);
(b) concluding and optimising laboratory/analytical evaluation to optimise test performance;
(c) completing its pivotal clinical trial program for the test’s initial intended use as an adjunct to mammography;
(d) developing its Health Technology Assessment (HTA) and reimbursement strategy;
(e) developing its test for scalability and ease of use;
(f) establishing its software tool for result analysis in a user-friendly manner;
(g) positioning itself for further clinical trial data to:
(i) broaden the use case for its technology domestically; and
(ii) explore pathways to regulatory approval in international jurisdictions; and
(h) meeting ongoing administration and corporate overhead expenses, including Offer expenses.
Investors should be aware there are significant risks associated with BCAL’s business, and an investment in the Company
should be considered highly speculative. These risks relate to matters including, but not limited to, regulatory approvals,
sufficiency of funding, healthcare insurance and reimbursement, regulatory requirements around clinical trials,
patent protection and currency risks. Please see Section 5 for more information on BCAL’s key risks.
I encourage you to read this Prospectus in its entirety to gain a full understanding of the Company’s operations
before making an investment decision.
On behalf of the Board, I commend this Offer to you and look forward to welcoming you as a fellow Shareholder
of the Company.
BCAL Diagnostics Limited