BioCurex, Inc.(fka BOCX)

[Gold Seeker]

Here are a couple of links that show how the process for a PMA works. What they are stating is rather conservative timewise but then again, Abbott is really, really slow also.

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Q: Has the APA Assay been approved by the U.S. Food and Drug Administration for use as a diagnostic test?
A: No, but the test is undergoing the clinical trials necessary to support a regulatory filing for FDA approval. For diagnostic tests, the FDA requires that tests be produced in kit form, and the kit is what the FDA approves and regulates. An APA Assay kit, in the Enzyme Linked ImmunoSorbent Assay (ELISA) microtiter plate format, has been developed for Autoimmune Technologies by Corgenix, Inc., and this kit is now being used in the U.S. clinical trials. The data obtained from these trials will then be submitted to the FDA in what is called a Pre-Market Approval, or PMA, application.

Q: How long do clinical trials take?
A: Unlike drug trials, clinical trials of a non-invasive blood test like the APA Assay can be done quickly, and the clinical trials of the APA ELISA Kit will probably take between six and nine months to complete. After that, the PMA application to the FDA will be submitted. If the FDA decides to approve the PMA, approval could come within six months to a year after the date of submission.

http://www.autoimmune.com/FAQ_eng.html
http://guidedtherapeutics.com/News/FDA%20Meeting%20January%202007.pdf