With 1 in 7 Australian women diagnosed with breast cancer, the demand for a minimally invasive, accurate diagnostic test is growing. Whilst health professionals recommend bi-annual breast screening for women aged 50-74, the invasive nature of imaging and ultrasound techniques leads to low compliance. There is well documented evidence that early cancer detection markedly improves patient outcomes, so how can we make sure that people are being screened appropriately?

In an effort to expedite diagnostic workflow, increase adherence to regular testing and increase accuracy in diagnosis, breast cancer screening and diagnostic company BCAL Diagnostics (ASX: BDX) is developing a minimally invasive blood test for breast cancer detection.

Results to date show the test to have 91% specificity and 87% accuracy.

The Company has partnered with the Sydney Breast Clinic to carry out a clinical program designed to validate the test and evaluate its performance compared to existing diagnostic measures.

The first phase of the trial will utilise the test as an adjunct to traditional mammography, to refine and improve insights gleaned from this commonly used diagnostic approach. This phase of the trial will outline the set of candidate markers used in the breast cancer diagnostic blood test to differentiate between healthy women and those with cancer.

The Sydney Breast Clinic is now collecting blood samples from patients having mammograms, with the NSW BreastScreen clinic at the Royal Prince Alfred Hospital to commence when they reopen in line with COVID guidelines. Collections are also expected to begin at other sites in the coming months. The Company intends to analyse 1000 participants’ blood samples to evaluate the accuracy and clinical validity of their test, as well as optimise the algorithm and establish protocols for test conduction.

Insights from the program will assist in developing clinical trial protocols and study design for further validation.

Executive Chair Jayne Shaw said: “Commencement of these studies marks a key milestone for BCAL as we further validate our test and continue toward commercialisation of a viable, accurate blood-based diagnostic for breast cancer diagnosis.”

Last year the global breast cancer diagnostic market was valued at USD $3.9 million and is expected to grow at a compound annual growth rate of 7% from 2021 to 2028.

According to the World Health Organisation, over 2 million new cases of breast cancer are diagnosed worldwide each year, and with regular screenings strongly recommended, the Company has significant market opportunity to introduce their minimally invasive, highly accurate diagnostic test to women of all ages.