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Jsattaw. The serum HER-2/neu which is not approved as a prognostic indicator. The current FDA cleared assay is cleared for the management and monitoring of patients with advanced breast cancer who have an initial value of over 15 ng/ml. Please note that any value under 15 ng/ml is normal. The serum HER-2/neu test is available in 2 formats. The manual test (ELISA ) is manufactured by Oncogene Science which is part of Bayer Dx. The manual test is distributed by DAKO. The automated version of the serum HER-2/neu is available on an instrument known as ADVIA Centaur. The automated test and the manual test have the same normal level of less than 15 ng/ml. There is only 1 serum HER-2/neu test cleared by the FDA and therefore the manual test distributed by DAKO and the automated test offered by Bayer are the same test with the same components. Labs that indicate that 12ng/ml is normal are correct but a second test showing that it is 14 ng/ml is also normal.
Research studies are ongoing to understand the clinical value of measuring serum HER-2/neu in early breast cancer but it is not cleared by the FDA for that use.
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