Genetic Test Complements Lung Cancer Diagnostics

A new laboratory test helps identify non-small cell lung cancer (NSCLC) patients who do not respond to targeted therapies.

Between 15 and 30% of tumors from NSCLC patients have mutations in the Kras gene,
and clinical studies show this information plays an important role in making treatment decisions. The Kras mutation analysis can help identify NSCLC patients who test positive for specific Kras mutations. The results will provide physicians and their patients with critical information to help determine how best to move forward.

The new Kras mutation analysis was developed by Genzyme Corporation (Cambridge, MA, USA). Mutations in the Kras gene have been associated with resistance to certain drugs currently used in treating NSCLC, including the tyrosine kinase inhibitors (TKIs) Tarceva (erlotinib) and Iressa (gefitinib).

Dr. Aspinall, president of Genzyme Genetics, noted that Genzyme believes effective cancer treatment is improved by personalized medicine--directing specific therapies at the patients most likely to benefit from them--and that this important convergence of diagnostics and therapeutics is a priority for the company. Recent clinical studies have shown that mutations in the Kras gene are found more frequently in patients who show limited clinical response or who have a shorter time to disease progression with TKI treatment.

In addition to the new Kras mutation analysis, Genzyme Genetics offers two other tests in its portfolio that help identify NSCLC patients likely to respond to TKI therapies. Epidermal growth factor receptor (EGFR) by fluorescence in-situ hybridization (FISH) was launched earlier this year and detects amplification of the EGFR gene, while the company's EGFR mutation analysis assay detects the presence of EGFR mutations in patients with NSCLC.



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