Veridex, a Johnson & Johnson company, is seeking Food and Drug Administration approval of its GeneSearch Breast Lymph Node Assay to find cancerous growths in lymph node tissue that has been removed from breast cancer patients.
An FDA advisory panel is scheduled to review the test on Thursday and make a recommendation on whether it is safe and effective enough to be marketed. The agency usually follows the recommendations of its outside advisers.
The test, which runs on Cepheid Inc.'s SmartCycler system, helps look for growths at least 0.2 millimeters in size by detecting expression of two genes -- Mammaglobin and Cytokeratin 19 -- usually seen at low levels in normal lymph node tissue, according to Veridex.
he results aim to help surgeons decide if more lymph nodes need to be removed.
FDA staff, in documents released ahead of the public meeting, questioned the company's lack of long-term survival data. They also questioned the exclusion of invalid test results when analyzing data on how well the test works.
"It is unclear to us what the implications of exclusion or inclusion have on the clinical utility of assay results," the staff wrote.
In separate documents also released on Wednesday, Veridex said data showed its test detected more cancerous growths compared to current techniques and causes no more risk.
"The benefits to a breast cancer patient of rapid, objective detection of clinically relevant ... metastases in the lymph node tissue outweigh any potential adverse event or risk to the patient or user due to assay malfunction or operator error," the company said.
GeneSearch also received approval in Europe in recent weeks, Veridex spokesman Steve Dnistrian said. He had no comment on the FDA staff documents or on the potential market for the test.
Shares of Johnson & Johnson were up 23 cents or less than 1 percent at $66.79 in afternoon trade on the New York Stock Exchange. Shares of Cepheid were up 25 cents, or 2.7 percent, at $9.45 on the Nasdaq.© Reuters 2006