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Genentech petition opposed

31st December 2008

Genentech’s citizen petition – filed earlier this month – has been opposed by the Coalition for 21st Century Medicine.

The campaign by the company seeks to restrict laboratories offering diagnostic tests to both physicians and patients.

A statement by the group said Genentech’s petition “threatens innovation in ? tests, would harm patient care and rests on flawed scientific and legal premises”.

It went on to note the campaign “relies on several incorrect assumptions” and “ignores that a rigorous, well-established regulatory system already exists for LDTs [laboratory developed tests]”.

Earlier this month, Genentech and Biogen Idec’s phase III trial of Rituxan found patients with early rheumatoid arthritis who took the drug had a decreased progression of joint damage.

The Image study saw patients – who had not previously been treated with methotrexate – receiving two doses of either 500 mg or 1,000 mg of the product.

Progress of any joint damage was assessed by X-ray images.

Speaking at the time, Genentech’s senior vice-president of development and chief medical officer Hal Barron said the results were “important”, noting the disability is believed to occur in the first two years of diagnosis.

Founded in 1976 by Robert Swanson and Herbert Boyer, the company was named in Fortune Magazine’s 100 Best Companies to Work For earlier this year.

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