Epidermal growth factor receptor (EGFR) gene mutations have been found in a 
subset of non-small cell lung cancer (NSCLC) with good clinical response to 
gefitinib therapy. A quick and sensitive method with large throughput is 
required to utilize the information to determine whether the molecular targeted 
therapy should be applied for the particular NSCLC patients. Using probes for 
the 13 different mutations including 11 that have already been reported, we have 
genotyped the EGFR mutation status in 94 NSCLC patients using the TaqMan PCR 
assay. We have also genotyped the EGFR mutations status in additional 182 NSCLC 
patients, as well as 63 gastric, 95 esophagus and 70 colon carcinoma patients. 
In 94 NSCLC samples, the result of the TaqMan PCR assay perfectly matched with 
that of the sequencing excluding one patient. In one sample in which no EGFR 
mutation was detected by direct sequencing, the TaqMan PCR assay detected a 
mutation. This patient was a gefitinib responder. In a serial dilution study, 
the assay could detect a mutant sample diluted in 1/10 with a wild-type sample. 
Of 182 NSCLC samples, 46 mutations were detected. EGFR mutation was 
significantly correlated with gender, smoking status, pathological subtypes, and 
differentiation of lung cancers. There was no mutation detected by the TaqMan 
PCR assay in gastric, esophagus and colon carcinomas. TaqMan PCR assay is a 
rapid and sensitive method of detection of EGFR mutations with high throughput, 
and may be useful to determine whether gefitinib should be offered for the 
treatment of NSCLC patients. The TaqMan PCR assay can offer us a complementary 
and confirmative test.