It has been approved in the US however they hadn't signed a distribution agreement in Australia. Simple.
The US market in its first quarter (not even full quarter) sold $700,000 of product. That isnt even the full available market in the US either. That is only to a cap of 10,000 labs. CLIA waiver will expand their reach to 220,000 GP offices.
UK, Europe etc don't have the same reimbursement structure as the US and Australia so its basically like selling cars to horse riders and expecting them to take it up straight away.
All you need to do is look at how quick the SP rose on FDA approval to see how quickly this can change.
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