Improved commercial prospects for blood-based test in early breast cancer

Biotech News: Australian breast cancer screening and diagnostic company reported independent results showing considerably reduced number of markers can be used to distinguish between blood samples of breast cancer patients and normal control samples.

BCAL Diagnostics is developing a blood-based test for the detection of breast cancer in its early stages. The test is based on disease-associated changes in the profile of lipids found in blood with technology that has the ability to revolutionise the breast cancer diagnostic industry.

BCAL Executive Chair, Jayne Shaw, said that the new independent review provides the Company with strong assurance in advancing the test’s development towards commercial use, both in Australia and the USA.

“This independent review confirms what we’ve long been confident of at BCAL, the ability to detect breast cancer using a lipid based blood test. The new developments solidify BCAL’s commercialisation pathway in the Australian, USA and European markets. As we welcome our new CEO Dr John Hurrell, BCAL will benefit from his strong leadership and detailed industry experience in moving the BCAL test to its next stages of development. We are thrilled by this outstanding advancement for BCAL within just six months since our IPO.”

Over the past 6 months, samples from a 4th cohort of patients have been examined, bringing the total of samples analysed in Australia since 2018 to 790. Examination of the data from the 4th cohort by the Company’s Australian team indicated that a signature with a reduced number of lipid markers than the original 18, as few as 6 to 10, might be sufficient for an effective clinical test. Such a reduction in the number of markers to be examined for each test considerably improves its commercial feasibility and attractiveness, reducing the time, cost and difficulty for analysis of each sample.

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Independently, BCAL contracted a third party to review the BCAL data and perform a retrospective analysis for the entire 790 samples collected. The review identified five small lipid signatures, with two particularly strong signatures whose performance strongly characterised samples from breast cancer patients when compared with normal controls. These signatures delivered strikingly consistent performance and are in agreement with BCAL’s local blind testing findings.

The combination of these local and international analyses supports BCAL’s goal of reaching a refined algorithm, facilitating acceleration of test development in a format that will be attractive both clinically and commercially. In addition, this greater refinement of the lipid marker panel has opened up the opportunity for BCAL to secure additional patent protection for its test.

The company told Health Industry Hub that it is aiming for a product launch by the end of 2023.