BioCurex, Inc.(fka BOCX)

[bocxman]

GoldSeeker: neither of those are straightforward general screening assays. they are both "novel" applications. the first one is for a unique subset (pregnant women
) and has a unique testing procedure...it was submitted as a package with the base assay, confirmatory assay, and third assay for "monitoring" performance. that is very different than a simple yes/no serum assay.

the second one is clearly a novel application as well...monitoring antibody response to a vaccine, testing for immune status, etc.

BOCX, kammerman, and others i've spoken to are telling me that a simple yes/no general screening cancer assay will be given SE status every time. take a look at the OIVD's criteria for SE (below), but more importantly speak to management and others because it is an important issue:

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SE means that the new device is as safe and effective as the predicate device(s).

A device is SE if, in comparison to a predicate device it:

has the same intended use as the predicate device; and


has the same technological characteristics as the predicate device; or


has different technological characteristics, that do not raise new questions of safety and effectiveness, and the sponsor demonstrates that the device is as safe and effective as the legally marketed device.