Genomic Health to meet with FDA to discuss premarket review of Oncotype DX

By Ted A. Knutson

Washington, Jan. 27 - Genomic Health, Inc. announced Friday it has received a letter from the Food and Drug Administration asking the company to meet with it to discuss the premarket review of Oncotype DX.

Oncotype DX is the company's genomic-based test for early stage breast cancer patients.

The company plans to meet with the FDA soon. In the meeting, the parties will discuss the nature and appropriate regulatory status of the company's technology and the least burdensome ways that the company may fulfill premarket review requirements, officials said.

Redwood City, Calif.-based Genomic Health is a life science company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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