ASX ANNOUNCEMENT – US FDA APPROVAL OF QuantiFERON(R) TB- Gold In-Tube Cellestis Limited advises that it has received notification from the United States Food and Drug Administration (FDA) that its advanced diagnostic for TB infection, QuantiFERON-TB Gold In-Tube (QFT-IT), is now approved for sale in the United States. The In-Tube product replaces the original version of QFT-Gold, and provides the same specificity and accuracy advantages. In addition, its In-Tube format provides an easier, safer and simpler test method, and allows an improved result and simpler adoption by customers. The In-Tube method is already widely used in Europe and many parts of the world. CEO of Cellestis, Dr Tony Radford, comments “With the In-Tube system the initial blood incubation needs virtually no labour and no set-up time. It makes a QFT test as simple as a routine antibody test, and extends the availability of QFT testing by streamlining the logistics, as its simple incubation process can be done almost anywhere. The FDA approval now allows our US customers to enjoy the cost-savings, and the quality result of In-Tube, as well as a better processing fit with hospitals and lab systems”.”
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