Huge milestone and major step towards commercialisation. The...

Huge milestone and major step towards commercialisation. The laboratory at North Ryde receives NATA, ISO15189 and NPAAC. The small delay may have been because 3 government departments had to co-ordinate between each other for the overall approval.

BCAL’s CEO, Shane Ryan commented, “NATA accreditation sends a very positive message to the medical community and women in Australia that our quality systems and processes meet the highest standards as outlined by NATA and NPAAC. The laboratory is now ISO 15189 certified which is an international standard for clinical laboratories and certifies that the laboratory quality systems, documentation and protocols meet the international and Australian standards.”

Clinical validation is in final stages. The Australian validation study has completed recruitment as per the presentaion on 22nd November (screen shot below) The data will be analysed prior to launch. This will not affect the launch dates clearly set out as Q1 starting with Victoria and NSW.

I have pasted the pivotal results from the US clinical validation study from August last year with Sensitivity of 90% and a specificity of 85.5% (see table comparing with other standard of care screening methods including mammograms) Note: I have highlighted where it reads these results were consistent with the findings of earlier studies in Australia with a different mass spec platform.