Ann: BCAL to Present at Bioshares Biotech Summit - Presentation, page-62

Others have covered off the first point of machine economics but this comment is categorically wrong.

"BDX thinks they don't need FDA approval (at least it's not in their project plan) or they can still operate but charge $$$"

FDA/TGA approval is absolutely in their plan and have conducted their data collection of previous trials and strategy with this end in mind. The difference with diagnostics to other drugs/devices is you do not need FDA/TGA approval to commercialise as a private test, the first step is NATA approval which is very close. I had pathology (fitness bloods) done this morning and was talking about Bcal to the lovely ladies. They said the sooner breast test can hit the market the better. They were genuinely excited and agreed women will pay $300 out of pocket to avoid a mam (until approved by FDA/TGA for reimbursement by medicare). The computer system they use offers a drop down box to populate the tests to be carried out from the pathology paperwork by the doctor.

Once Bcal get NATA accreditation Breasttest will be part of this dropdown option. Then once the awareness campaign with GP's and specialists leveraging the help of the breast NGO's associations and networks listed here, there will be a significant market for out of pocket test.