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Not to spoil your day or anything like that, but it turns out that by
Jan 1995, the FDA will hand down its ruling concerning the use of Monoclonal AB
for In Vivo diagnostic use. To date many AB used for Flow have not been
approved. Only T cell stuff from BD, Coulter, and some Ortho ab are approved.
Some B cell stuff is in the pipeline, and to my knowledge, I could not get a
straight answer about the myeloid stuff.
The FDA wants to make all monoclonals a Class 2 product insted of a
Class 1 product. This will force the manufactures to spend huge amounts of
dollars to get their ab on the market. we are talking somwhere between 300K
to 500K per antibody. Even Worse, many markers like p53, MIB1, and Her2/nu
will have to go into a Class 3 since these will be considered prognostic
markers. That means clinicl trials for these markers.
Well besides the price of Flow sky rocketing since we will have to more
for supplies, and having a limited number of things we can do with our
instruments in the clinical setting, life should go on as usual. I just want
to know what others think about the situation, and if they have any plans to
deal with the fact that we may loose over half of our monoclonal antibodies.
take care -- rr
-- Robert O. Rainer, M.D. drwho@pandoras-box.bgsm.wfu.edu Department of Pathology Bowman Gray School of Medicine phone (910) 716-4311 Winston-Salem, North Carolina Fax (910) 716-7595 27157
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