Test Individualizes Lung Cancer Therapy

A new laboratory test helps doctors identify patients likely to respond to therapies targeted for the treatment of non-small cell lung cancer (NSCLC).

The epidermal growth factor receptor (EGFR) mutation assay will help to detect the presence of EGFR mutations in NSCLC patients. These mutations have been shown to correlate with clinical response to certain drugs, including Tarceva (erlotinib) and IRESSA (gefitinib), used in treating lung cancer. The test was developed by Genzyme Corp. (Cambridge, MA, USA).

The EGFR mutations were discovered by researchers at Dana-Farber Cancer Institute and Massachusetts General Hospital, both affiliated with Harvard University (Boston, USA). They analyzed tumor samples from lung cancer patients who had responded to tyrosine kinase inhibitors of EGFR. A majority of patients who responded to therapy had the mutations. The exclusive worldwide diagnostic rights to EGFR mutations in NSCLC tumors are held by Genzyme, which developed the new test. Mutation testing may allow Tarceva and IRESSA to achieve approved indications for first-line use in NSCLC patients who have the EGFR mutations and are therefore more likely to respond to these therapies.

EFGR mutation analysis combines polymerase chain reaction (PCR) testing and gene sequencing technologies for the detection of somatic mutations in NSCLC tumor tissue. Cells from specific tumor-rich areas are microdissected, followed by DNA extraction, PCR amplification, and bi-directional sequencing of exons 18 through 21 in tyrosine kinase domain of the EGFR gene.

"With this test, the rationale for prescribing specific lung cancer therapies may be individualized and we can help physicians and patients choose the best treatment possible,” said Mara Aspinall, president of Genzyme Genetics, which focuses on diagnostic testing services. "This is ‘personalized medicine' in action.”





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