No mentions of FDA submission, believe it or not its been 17months since they announced intention to submit FDA approval for IVD and they still have not submitted it, so something doesn't sound right there. Last mentions of FDA were pending ISO completion; which they since confirmed 2 months ago but still not FDA update. US rollout is only for LDT kit - would be interesting to know how many CILA labs SH have in the US.
From ASX 28 Apr 2022.
Hope this helps?
Ann: Proteomics signs binding LOI with Sonic Healthcare USA, page-44
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