BD1, page-17

Assay development is currently underway by our contract development partner Thermo Fisher Scientific to transfer the research assay to Luminex® instrumentation. Clinical studies are then expected to commence in 2H19 for both BARD1-Breast and BARD1-Ovarian to evaluate clinical performance with expected launch as Laboratory Developed Tests (LDTs) in 2021.

The Company's business strategy is to leverage its BARD1 Technology to develop diagnostic tests for early detection of cancer when it can be potentially cured. The Company plans to develop a portfolio of non-invasive diagnostic tests for early detection, diagnosis or monitoring of cancer, conduct clinical studies to demonstrate the clinical performance of its BARD1 Tests and enable medical device marketing, and then commercialise its products through licensing its diagnostic tests to clinical laboratory, major diagnostic or biopharmaceutical partners in the USA, Europe and Asia.

I do recall reading that applications for FDA approval will follow at some point after licencing it's diagnostic tests through partnership/s as stated above..