Hugh
I can concur with you on the US portion. For example the Vitros ECi Total hCG assay has 2 separate Instructions For Use. The US IFU has no oncology claim as there is no FDA approval. The European version does describe the use of hCG in oncology settings. In the US in order to meet the claim requirement clinical trial data must be submitted to the FDA and approved.
I am not aware of any vendor selling hCG kits in the US that have an oncology application in their labeling.
Joe
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Hugh Mitchell
Sent: Wednesday, October 08, 2008 1:32 PM
To: [log in to unmask]
Subject: Re: HCG as a tumour marker
Dear Colleagues
I believe Dr Watine's interpretation is not correct: I cannot find
the conclusion that any of the current hCG kits are suitable for
oncology - perhaps Cathie Sturgeon will give her interpretation.
The most positive step would be for each user to write to their hCG
kit supplier and ask whether their kit is suitable for oncology. I
predict that for most kits the reply would be negative. Roche might
reply in the affirmative, but only for their European kit. In the US,
no commercial kits for hCG have FDA approval for oncology.
Hugh Mitchell
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