Re: Bye the way:
in response to
by
posted on
Oct 09, 2012 10:20AM
Paramagnetic Beads and QL Analyser are Proprietary Products
Wow,
My opinion regards the need for clinical data to support commercialization of the beads is based on more than 25 years of management experience with established and start-up healthcare companies.
Regards your statement that the beads "...don't require the test" is incorrect; Dr G has informed us that an IVD Company will have to file a 510K with the FDA should they wish to replace the dark iron beads currently used in the FDA cleared diagnostic machines with Cardiogenics silver coated beads. IMO a prudent management team of an IVD company will require clinical data to support such a regulatory filing.
Ante