As someone that's in this field - I can tell you that they will need TGA/FDA to get this test to be accepted into the AUS and US market. Also what kind of NATA accreditation are they going for? Biomedical NATA accreditation is not easy to achieve - and can take many years!
PS. There are also many other companies that are developing Lipidomic tests for cancers/cardiovascular disease (as they are the biggest disease burden on the community); so I cant see why their product is any better IMO. Quite risky!
Ann: Company Presentation - Investor Insights, page-39
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