The ratio of HER-2/neu (ERBB2 gene) to CEP17 probes by in situ hybridization assays (e.g. FISH) to determine overexpression of HER-2/neu protein in breast cancer. CEP17 is used as an internal control and to account for aneusomy (varying number) of chromosome 17. A ratio of >2.0 indicates gene amplification and overexpression of HER-2/neu according to the 2013 ASCO-CAP HER2 test guideline recommendations. Results are used to assist in dose selection for certain drugs, assess eligibility for trastuzumab (Herceptin®) treatment, predict response to drug therapies and overall survival in patients with breast cancer. For testing without an internal control probe, see LOINCs 31150-6 and 48675-3. For determining HER-2 status by Immunohistochemistry (IHC), see LOINC 18474-7.
status
ACTIVE
Fully-Specified Name
component
ERBB2 gene copy number/Chromosome 17 copy number
property
NRto = Number Ratio
time
Pt = Point in time: To identify measures at a point in time. This is a synonym for “spot” or “random” as applied to urine measurements.
system
Tiss = Tissue, unspecified
scale
Qn = Quantitative: The result of the test is a numeric value that relates to a continuous numeric scale. Reported either as an integer, a ratio, a real number, or a range. The test result value may optionally contain a relational operator from the set {<=, <, >, >=}. Valid values for a quantitative test are of the form "7", "-7", "7.4", "-7.4", "7.8912", "0.125", "<10", "<10.15", ">12000", 1-10, 1:256
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