The title "Turning Glitter to Gold" by Prof Barnes is not an isolated statement but more a comment regarding the evolution of Quantiferon from that initial FDA approval.
Whilst the 2001 FDA panel decision was unanimous they were understated in their remarks, "We felt that given the limits of the tuberculin skin test, [Quantiferon] offers advantages," and "We felt that the concordance issue wasn't as important as being able to get results."
The CDC was more enthusiatic; "For the first time in a hundred years, we have a new test to aid in the diagnosis of latent TB infection"
"It's not a perfect test yet, but this gives us the framework in which to evolve".
The work set out by the CDC has been completed and those results put before FDA panel and now its a matter of finalising the due process.
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