The USA’s Genzyme Corporation has launched a novel laboratory test designed to assist in the identification of patients who are most likely to respond to therapies for the treatment of non-small cell lung cancer.

The EGFR Mutation Assay helps to detect the presence of epidermal growth factor receptor mutations in patients with NSCLC, which are linked to the clinical response to certain drugs, such as Roche’s Tarceva (erlotinib) and AstraZeneca’s Iressa (gefitinib).

"Up to 20% of patients with non-small cell lung cancer test positive for the EGFR mutation," stated Mara Aspinall, president of Genzyme Genetics, which focuses on the research and development of diagnostic testing services. "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. This is `personalized medicine' in action," she added.

Drugs such as Tarceva and Iressa are currently used to treat NSCLC patients who have failed one or more chemotherapy regimens, representing around 30% of total NSCLC cases. Clinical evaluation of these products for first-line therapy is ongoing, and mutation testing could help them attain approval for first-line use in subjects who have these EGFR mutations and are, therefore, more likely to respond to treatment.

The EGFR test may have further application in other cancers, and researchers are currently looking at similar mutations in other tumour types in order to determine whether testing can help patients gain access to more effective, targeted therapies.

"Knowing at the onset whether a lung cancer patient is likely to benefit from a specific therapy is a significant advance in the treatment of lung cancer," commented Matthew Meyerson, MD, PhD, associate professor of pathology at Dana-Farber Institute, who was also involved in the discovery of the EGFR mutation. He went on to say that the test “is an important first step in the development of rational and tailored lung cancer therapies."

According to a recent report by the UK’s Royal Society, the dawn of personalised medicines could be at least 15 to 20 years away, mainly because of gaps in understanding of how genetics relate to the cause of disease [[22/09/05e]]. However, the launch of Genzyme’s new lung cancer test indicates that the age of targeted therapies could be one step closer.