If your patient is participating in a clinical trial (Herceptin), you are required to test using the FDA approved methodology. Until recently, DAKO had the market in regard to FDA approval so Herceptest was indicated. One side note - if you are performing an FDA approved test and advertising it as such you must follow the FDA approved protocol. This represented a little bit of problem for some of us who didn't want to retrieve using the waterbath DAKO specified. Now that Ventana has achieved FDA approval, their protocol must be adhered to in order to achieve the FDA seal. One would probably have to check on acceptance as it pertains to clinical trials on using the Ventana antibody as opposed to DAKO.
If a lab chooses to perform Her2 by a non-FDA approved antibody, they should handle it as they would any other immuno according to the information within the package insert - the biggest burden being to the testing facility if using an ASR. Reimbursement is usually determined by CPT code and I believe most third-party entities pay 88342 without FDA being required, although I've heard they could refuse.
Hope this helps.
>>> "Einfalt, Ginny" 11/09/01 05:25PM >>>
We are in the process of bringing our breast cancer panel in house. We
have a Ventana ES and NexEs. We are considering the Benchmark, but due to
finances will probably be putting that off until next year. I don't see the
ER or PR as a problem, but I am concerned about the HER2. I understand that
only Dako and Ventana are FDA approved and the cost of the Pathway Her2 is
$2500 for 50 tests. Does anyone know what the reimbursement is for this
test and if it is worth the investment? Is there a more cost effective way
to do HER2 and still meet insurance and legal guidelines? I would appreciate
hearing from those of you who have added HER2 to your breast cancer panels
in the last year.
"MMS " made the following
annotations on 11/12/01 13:09:52
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