Panel Rejects Cancer Gene Test Kit

Government scientists Thursday rejected the first genetic test kit designed to predict which breast cancer patients could relapse after surgery and thus need tougher treatment.

The test detects a gene believed to spur cancer cell growth. Several hospitals already check Americans with small, early tumors for the gene in deciding how aggressively to treat them.

But those tests are experimental, performed with little government oversight, and their accuracy differs from lab to lab, said Dr. Dennis Slamon of UCLA.

Oncor Inc.’s Inform is trying to become the first Food and Drug Administration-approved test for the gene.

But an FDA advisory committee on Thursday said Oncor’s study of 244 women was not large enough to prove testing for the HER-2/neu gene either worked properly or was useful in deciding how to treat breast cancer. By a 6-1 vote, the panel said Oncor should study many more women; one panelist recommended 2,000.

The FDA is not bound by advisory committee decisions but usually follows them.