IMMUNOLOGY DEVICES PANEL RECOMMENDS APPROVAL OF J&J BREAST CANCER DIAGNOSTIC

The Immunology Devices Panel of the FDA's Medical Devices Advisory Committee Nov. 16 recommended approval with conditions for the Veridex GeneSearch lymph node assay by a vote of 9-1.

The product is a gene-based test to rapidly detect "clinically relevant" cancer cells in lymph node tissue removed from breast cancer patients. It is made by Veridex, a unit of Johnson & Johnson subsidiary Ortho-Clinical Diagnostics.

According to an FDA spokeswoman, to meet the conditions of approval set by the FDA advisory committee, the firm must:

Conduct a postmarket study;

Separate patient tissue to facilitate performance of the test;

Provide user training;

Establish a postmarket database to capture patient results; and

Make labeling adjustments.

"We are expecting a final decision [on approval] by the first quarter of next year," Steve Dnistrian, Ortho-Clinical's vice president of worldwide corporate communications, said.