Ann: Breakthrough Results a Major Step Towards Commercialisation, page-21

It looks like they'll go for priority TGA approval. Which makes sense if they've got a clinic here.

In the next phase of its work, BCAL will undertake studies designed to demonstrate the value of its test in improving diagnosis of breast cancer when it is used alongside mammography as an adjunct test, with its initial regulatory focus on seeking approval from the Australian Therapeutic Goods Administration (TGA). The TGA approval sought will be for priority review status for BCAL’s IVD test to be used as an adjunct to traditional mammogram screening. BCAL’s present and future clinical studies are also designed to support future regulatory approval pathways.