BCAL Diagnostics (ASX: BDX) has launched a first-in-class blood test known as BREASTEST plus to address the challenge of high breast density, which can impact standard-of-care breast cancer screening practices.

The company designed the lipid test for use alongside traditional mammogram imaging and it has been validated to meet the challenge of high breast density, which affects approximately 50% of Australian women participating in breast cancer screening programs.

The new test will be available at Sydney Breast Clinic from 27 March, followed by a planned rollout to select clinical sites nationwide starting with Sydney and Melbourne.

Difficult to detect

Breast density – which reflects the proportion of fibrous and glandular tissue versus fatty tissue in the breasts – shows up as white regions on a mammogram.

This can obscure abnormal lesions and make it difficult to detect any cancerous growths.

Statistics show that a mammogram’s sensitivity drops from 90% in low-density breasts to 64% in high-density breasts and women with dense breasts are up to five times more likely to develop breast cancer.

BCAL developed BREASTEST plus in collaboration with its clinical advisory board, comprising leading Australian breast surgeons, radiologists and physicians, to ensure it meets the needs of women with high breast density.

Targeted timeframe

BCAL chief executive officer Shane Ryan said the company had delivered the blood test to market within its targeted timeframe.

“The commercial launch of BREASTEST plus is an incredible milestone for us and for the future of breast cancer screening,” he said.

“This innovative blood test has the potential to significantly improve the early detection pathway of breast cancer and we look forward to ensuring widespread adoption nationwide, supporting women and clinicians with cutting-edge screening tools.”

‘Vital step forward’

Breast surgeon and BCAL clinical advisory board head Dr David Speakman welcomed the new precision medicine blood test.

“Anything we can do to detect breast cancer earlier, to rule it in or out, is a vital step forward for women and saving more lives,” he said.

“This simple blood test can aid clinicians and their patients in assessing for any sign of breast cancer, which is a step change from relying on breast imaging alone.”

Self-developed patent

Government agency IP Australia has granted BCAL its first self-developed patent, Diagnostic Signature, further reinforcing the company’s innovative approach to breast cancer diagnostics.

The patent secures key methods and lipid markers integral to BREASTEST plus technology and provides the company with intellectual property protection through to 2043.

Mr Ryan said BCAL also retained exclusive global rights to intellectual property related to the application of lipidomic information in the diagnosis of cancers from the University of Louisville in the US.