GENZYME'S NEW DIAGNOSTIC MONITORS GLEEVEC RESISTANCE

Biotech firm Genzyme has launched a diagnostic test to monitor drug resistance in chronic myeloid leukemia (CML) patients who are treated with Novartis' cancer drug Gleevec.

Genzyme's new BCR-ABL Mutation Analysis test will help physicians evaluate resistance to therapy and facilitate appropriate adjustments to treatment, the firm said. Despite high response rates to Gleevec (imatinib mesylate) roughly 4 to 5 percent of patients who were initially treated successfully will develop resistance during therapy, Genzyme added.

The molecular hallmark of CML is a mutation known as BCR-ABL. The mutation is the specific target for Gleevec, and is found in 95 percent of patients with CML, the company said.

In relapse patients, the majority of secondary mutations in the ABL portion of the gene correlate with treatment failure. Genzyme's new test detects all secondary BCR-ABL mutations and therefore predicts resistance to Gleevec.

This test provides with leukemia patients and their caregivers more information about their disease and will give them the ability to personalize their treatment, said Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme focused on the research and development of complex testing services.