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Genzyme Test to Bolster Lung Cancer Treatments (Update1)

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http://www.bloomberg.com/apps/news?pid= ... fer=canada

Sept. 27 (Bloomberg) -- Genzyme Corp. will market a test designed to help predict which lung cancer patients may respond best to some therapies.

Genentech Inc.'s Tarceva and AstraZeneca Plc's Iressa effectively treat about 20 percent of patients with non-small cell lung cancer, the most deadly form, studies show. The trick is to identify ahead of time which patient may be helped.

The $975 test examines the genetics of tumors removed for biopsy for mutations that make them susceptible to treatment, Cambridge, Massachusetts-based Genzyme said in a statement today. The results may also help Genentech and AstraZeneca win regulatory approval for use of their drugs as initial therapies. They currently are approved for use only after other drugs fail.

``We're at the beginning of personalized medicine,'' said Mara Aspinall, president of Genzyme Genetics, in a telephone interview today. ``This is one important piece of information that the physician needs to know to make the best treatment decision for those patients.''

Shares of Genzyme fell 72 cents to $69.67 at 1:15 p.m. New York time in Nasdaq Stock Market composite trading. The stock has risen 21 percent so far this year before today.

The test, called the EGFR Mutation Assay, is currently available and should be covered by insurance, Aspinall said. The U.S. Food and Drug Administration doesn't require formal approval before selling diagnostic tests.

Growing Knowledge

Researchers at Dana-Farber Cancer Institute and Massachusetts General Hospital in Boston found that mutations in the epidermal growth factor receptor in cancer cells affect the potency of drugs like Tarceva and Iressa, which block the EGFR pathway needed for cancer growth. Genzyme licensed the rights to the discovery in lung cancer tumors.

The test builds on the growing knowledge, supported by the Boston research, that not all lung cancers are the same. In the past, treatment was a trial and error method based on what drugs were most effective in general, without knowing whether a patient's disease resembled an average or unusual case.

``This isn't about average,'' Aspinall said of the new test. ``It's about what kind of cancer you have and what's most likely to work.'' The test may also save money if it helps guide therapy, Aspinall said, noting that studies have shown about half of drugs don't work for the patient getting them.

`The Right Drugs'

``If we can better figure out which are the right drugs for the right patient at the right time, we're better utilizing health care resources and better treating patients,'' she said.

Tarceva, a pill that can be taken at home, costs more than $2,000 a month. Iressa costs about $1,800 a month.

Iressa is only available in the U.S. for patients who began taking the treatment before a study showed the medicine didn't help patients live longer. Some doctors believe Iressa will prolong life for patients who have the gene mutations detected by Genzyme's test.

An AstraZeneca spokeswoman declined to endorse the Genzyme test. A spokesman for Genentech didn't immediately return telephone calls for comment.

``This test needs to be verified in clinical trials'' that include information on its accuracy, said AstraZeneca spokeswoman Mary Lynn Carver. ``But anything that provides more information for patients and their doctors in making a treatment decision is a step in the right direction.''

Researchers are allowed to use genetic tests similar to Genzyme's as part of their clinical studies. Because of Genzyme's license, however, others aren't allowed to sell the test commercially to doctors or their patients.

About 174,000 people in the U.S. were diagnosed with lung cancer in 2004, and 160,000 died from the disease, according to the American Cancer Society.

To contact the reporter on this story:

Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

Last Updated: September 27, 2005 13:19 EDT

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