The following is based on information found in the latest (November) 10-QSB, and some is from the July 2005 Research Notes. My interest in this was sparked by trying to find out what BioCurex was actually saying about how the FDA might classify the RECAF screening tests as medical devices. The question is, will the tests be classified by the FDA as class I, II, or class III medical devices?
1. The Histo-RECAF kit is “listed” by the FDA as a class I medical device. It is not partnered and none of the kits have been sold.
2. The Cryo-RECAF kit is not partnered, and none of the kits have been sold. BOCX has not applied to the FDA (or to Canada’s equivalent regulatory agency) for permission to sell the kit. Therefore, its classification by the FDA, as a medical device, is presently unknown.
3. BioCurex has developed a serum RECAF cancer screening assay, and has licensed certain aspects of that technology to Abbott Laboratories. BioCurex expects to enter into other licensing agreements (like Abbott’s) in the coming months. BioCurex retained all rights to its prototype serum RECAF cancer screening assay (this implies that Abbott could develop its own version of the serum RECAF cancer screening technology) and BioCurex plans to commercialize its prototype serum RECAF cancer screening test directly to clinical laboratories as ASR’s (Analyte Specific Reagents) for production of “home brew” tests. BioCurex mentioned that there is a new FDA regulation which allows certain individual reagents to be available for clinical laboratories to use in their own in-house developed “home brew” tests, without requiring manufacturers, like BioCurex, to submit 510k’s or PMA’s for the majority of individual reagents involved in the test. This regulation could allow clinical laboratories to produce serum RECAF tests based on Biocurex’s prototype format without the need for a lengthy FDA approval process.
My personal reaction to any company (like BioCurex) trying to market any “home brew” cancer screening test is “good luck”, because it most likely will never fly. Any successfully marketed new test requires a well-established sales force, like any of the big clinical diagnostics companies already have in place, to “educate” doctors as to what the new test can do, so that doctors will order that the test be done on their patients. There are huge costs involved with successfully marketing a new medical product or test. It is also my opinion that screening tests will have to be designed to run on these fast, automated systems like Abbott’s Architect system in order for any test to be successfully marketed. The day of manually testing lab samples is on its way out, and the automated testing segment of the market is well on its way in.
So, it appears that it is not presently known how the FDA may classify Abbott’s version of the serum RECAF cancer screening test. Be assured that Abbott has a pretty good idea how it will be classified as a medical device, and, if possible, will design the test to their greatest advantage concerning obtaining earliest FDA approval. BioCurex states that Abbott will likely initially develop the serum RECAF screening tests for prostate and colon cancer, and expects to see the first serum RECAF cancer screening test in 12-18 months, and the second in 24 months. That is not a long wait expecially since about a year of that time has already passed. Our best assurance at this time is the fact that Abbott has had the RECAF technology in their hands for almost a year, and Abbott knows how to correctly do things to make things happen. As I have posted before, Abbott is currently sustaining double-digit annual growth in most of their product lines. kag
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