This Access QFT test will not have to go through as much FDA rigor,as other Ellume tests in development as it's Parent test is already approved, its just a format change.
Qaigen recently got approval to tweek their Whole Blood TB test -
P010033/S031
06/07/2017
N - Normal 180 Day
QUANTTFERON-TB GOLD PLUSQIAGEN
Approval for a design change to the device TB Antigen blood collection tubes.
AnteoBind?
Ellune/Anteo/Qaigen/ sandwich?
Maybe.
Ellume, partner or not?, page-73
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