Quantiferon clearing FDA hurdles so far?
Approval process speedier than some
Quantiferon, the new, one-step diagnostic test for TB infection that has clinicians chomping at the bit, has reached the halfway mark in the approval process at the Food and Drug Administration (FDA).
The approval process for the blood test is moving along more speedily than usual, in part because the federal agency has asked for data to be delivered in the form of three modular "sets" instead of one huge chunk. "In the standard procedure, they take a submission the size of several phone books and look it for several months. The modular system expedites things," says Antonino Catanzaro, MD, professor of medicine at the University of California at San Diego Medical Center.
Because the test uses a blood draw, not an intradermal injection, patients don’t have to return at a later time for interpreting results. Just as exciting is the fact that trial data (along with cultures from cattle) suggest the test is at least as accurate as the tuberculin skin test, and perhaps more adept than the TST in distinguishing TB infection from BCG vaccine or infection with atypical mycobacteria.
Quantiferon was originally developed by an Australian veterinarian. An Aussie company called CSL purchased it and began testing its utility in humans. Then, says Catanzaro, CSL decided to focus on blood-bank-related products and decided to sell its animal-products line.
At that point, the crew that had originally sold the test to CSL decided to form their own company — Cellestis Ltd. — and promptly bought it back. Catanzaro, who had been asked to serve as a consultant to CSL, was recruited to Cellestis’ board of directors.
Catanzaro is optimistic about both the test and the FDA approval process. "I think this drug has some very appropriate applications," he says. "I was also very encouraged by news releases about the new drug for cancer [Gleevec]. They not only approved it, they seemed positively passionate about it." Maybe the unprecedented show of enthusiasm means there’s a "new era" dawning at the federal agency, he adds.
The real problem may be convincing the more conservative community of public-health wonks to adopt the new tool, he adds. Catanzaro says one of his former mentors used to sum it up this way: "It takes 25 years for a major advance in public health to get adopted because it takes that long for someone who learned about it in medical school to become head of the program."
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