BCAL Diagnostics takes major step forward in commercialising blood test for breast cancer screening

Australian biotechnology company BCAL Diagnostics (ASX: BDX) has announced breakthrough results from a clinical study of its non-invasive blood-based test for detecting early-stage breast cancer.

Sponsored by US commercialisation partner Precion Inc, the study achieved a test sensitivity rating of 90% and a specificity of 85.5%, both of which were consistent with the findings of earlier studies conducted in Australia using a different mass spectrometry platform.

BCAL said the validation shows “strong potential performance” with a balance of sensitivity (ability to detect true positive samples) and specificity (ability to detect true negative samples).

The replication of the results is considered a major step forward in the journey towards commercialising the BCAL test in the second half of calendar 2024.

It means the test should be capable of being replicated in BCAL’s dedicated Australian laboratory (which opened in Sydney earlier this year) and in commercial laboratories worldwide.

This is expected to fast-track the company’s access and penetration into existing and new markets globally.

Significant development

Executive chair Jayne Shaw said the results were a significant development and vindication of BCAL’s efforts over the past decade and since listing on the ASX in 2021.

“These results are a major step towards making our test broadly available to patients and clinicians,” she said.

“We will continue to work closely with leading scientists and doctors as our science team further optimises the test to make it more cost-effective when it is launched as a patient-friendly blood test for detecting breast cancer.”

Disease-associated changes

BCAL’s blood-based test is based on disease-associated changes in the profile of lipids (or fats) found in blood.

It will initially be used alongside screening technologies such as mammograms while the company progresses the development of a standalone monitoring and screening test suitable for women of all ages and backgrounds.

Precion was appointed last year and brings to the table extensive scientific experience, advanced technology and a track record of developing and validating commercial biomarker assays using mass spectrometry.

Ms Shaw said BCAL continues to work with leading breast cancer radiologists, surgeons and oncologists to guide the development and commercial strategy for the breast cancer blood test.