abbot conducted an assessment of the omicron variant and are confident their test will detect omicron and are good to go manufacturing 100+ million tests a month BUT the TGA are making us do a clinical trial.
I haven't found any definitive facts but the tests approved in the last month by the TGA wouldn't have had the time to perform a trial but got approval.
its all very suss
Ann: TGA Registration Update, page-1664
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