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FDA IMMUNOLOGY DEVICES PANEL TO MEET

October 2, 2006

The Immunology Devices Panel of the FDA's Medical Devices Advisory Committee will hold a public meeting Nov. 16.

The committee will discuss, make recommendations on and vote on a premarket approval application for a laboratory assay designed for the rapid detection of "clinically relevant" metastases in lymph node tissue removed from breast cancer patients, the FDA said.

"Results from the assay can be used to guide the surgeon's decision to excise additional lymph nodes and aid in staging," the agency said.

The meeting notice can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/2006-4249-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2006-4249-nm00001.pdf).