BCAL Diagnostics Limited (ASX: BDX) has received breakthrough results from a clinical study it sponsored with Precion Inc. in North Carolina, US.
The analysis undertaken achieved an impressive sensitivity of 90% and a specificity of 85.5%. These results were consistent with the findings of earlier studies conducted in Australia using a different mass spectrometry platform. This 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 these results is a major breakthrough in the path to commercialisation of the BCAL test. These results enhance the confidence of the company that the BCAL blood-based test for detecting breast cancer will be available for commercial sales, in conjunction with mammograms, in the second half of calendar 2024.
The results mean that the BCAL test should readily be capable of being replicated not only in BCAL’s dedicated laboratory in Australia but, more importantly, will enable blood samples to be analysed (using the BCAL test) in commercial laboratories throughout the world. This will fast-track BCAL’s access and penetration into existing and new markets globally.
The Board and executive management of BCAL consider these results to be a very significant development and vindication of the efforts of the BCAL team over the past 10 years, particularly since BCAL listed on the ASX in 2021.
These results are a major step towards making our test broadly available to patients and clinicians. 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,” Executive Chair, Jayne Shaw, said.