The FDA will not shut GCDX down until he has some actual sales. That is just the way the FDA currently works.
Provista attempted to sell their BT test back in 2008 and was selling it via CLIA labs. The FDA shut them down. Currently, the BT test is selling in the UK and Ireland. Reese claims he will have the necessary clinical data to submit a 510k this year. Reese will definitely have a problem if their patent application is not approved.
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