BCAL inaugurates new lab for breast cancer screening, works with US partner to validate machine

In 2018, breast cancer was the second most common form of cancer diagnosed across Australia. And in 2022, there were over 20.6k new cases of breast cancer in the country. Like with most medical concerns, early detection is optimal to begin treatment and put dire consequences to rest. In case of breast cancer, breast cancer screening and diagnostic company BCAL Diagnostics (ASX: BDX) has developed a blood-based test to initially accompany other early diagnosis tests.

The test is centered around changes in the composition of fats (lipids) present in the blood, which are linked to specific diseases. BCAL’s test, known as BCAL Dx, has demonstrated a high level of accuracy in identifying patients with breast cancer. This test will serve as a valuable addition to mammography, which is currently the primary method used for breast cancer screening. 

BCAL cited market research, which noted that as many as 50% of eligible women do not undergo mammography, and its effectiveness can vary significantly based on factors such as the radiologist’s expertise and individual physiological differences among women. Moreover, mammography may not be as effective in detecting breast cancer at its early stages and in younger women. 

So, in early May 2023, BCAL officially inaugurated its development and clinical service laboratory. The laboratory is equipped with the latest Liquid Chromatography Mass Spectrometry (LCMS) platforms, enabling the company to build upon its existing clinical research findings. BCAL aims to further progress the work achieved by its US commercialisation partner, Precion, in validating workflows, test protocols, and algorithms for the BCAL blood screening tool.

As part of the laboratory setup, BCAL has acquired an Exploris 240 LCMS machine, which has undergone performance and validation checks. Additionally, BCAL has been loaned a TSQ Altis Plus QQQ machine, previously utilised by Precion, to cross-validate their results.

The BCAL laboratory will serve as the testing site for both ongoing and planned clinical validation studies. Moreover, the laboratory will establish the necessary quality systems and protocols to comply with ISO 15189, CLIA accreditation, NPAAC (National Pathology Accreditation Advisory Council) certifications, and meet the requirements of the Therapeutic Goods Act 1989 (Cth).

BCAL’s initial commercial goal is to make its blood-based test available to the medical community in Australia. This test will serve as an additional tool for physicians to aid in making clinical decisions.

Moreover, Precion, BCAL’s US partner, analysed 656 plasma samples using its newly developed method. The data was forwarded to Sydney for statistical analysis, and the lipid extracts were sent to BCAL for comparison with its LCMS machine. Consistent results on different machines are vital for future implementation in pathology labs.

BCAL is also discussing collaborations with cancer research leaders to use its lipidomics platform for early detection in prostate, ovarian, and brain cancer. This could increase sample numbers, reduce costs, and broaden BCAL’s commercial revenue base.

Plus, during the June 2023 quarter, BCAL hired David Darling as an advisor. Prior to this, Darling served as the CEO of Pacific Edge, a NZX50 company specialising in the global commercialisation of bladder cancer diagnostics tests.

BCAL’s expenditure over the past two years, after accounting for the R&D tax offset, stands at approximately $10 million. At the end of the quarter, the Company has $3.2 million in cash, down from $5.2 million in the previous quarter. BCAL is awaiting an ongoing R&D tax offset claim of approximately $2.5 million, which is in progress.

In H1 FY23, the Company saw its losses shoot up by 88% to $2.4 million, as its revenue stood at $1 million. With the new lab being set up and an R&D rebate in progress, BCAL is sure that it is well-funded for the near future.