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Table 2 UCCC criteria for stratification of NSCLC patients according to the EGFR FISH assay.

From: Stratification of non-small cell lung cancer patients for therapy with epidermal growth factor receptor inhibitors: the EGFR fluorescence in situ hybridization assay

EGFR FISH Positive
• Specimens with EGFR gene amplification, defined as:
   (a) EGFR gene to CEP 7 ratio ≥ 2
   (b) Small gene cluster (4–10 copies) or innumerable tight gene cluster in >10% the tumor cells independent of the EGFR to CEP 7 ratio
   (c) Larger and brighter EGFR signals than CEP 7 signals in >10% the tumor cells while EGFR signals are smaller than the CEP 7 signals in the adjacent stromal and reactive cells independent of the EGFR to CEP 7 ratio
   (d) >15 copies of the EGFR signals in >10% of tumor cells independent of the EGFR to CEP 7 ratio
• Specimens with ≥ 40% of cells displaying ≥ 4 copies of the EGFR signal
EGFR FISH Negative
• Specimens without gene amplification as defined above and with <40% of cells displaying ≥ 4 copies of the EGFR signal