FDA Approves Oncor Breast Cancer Test

Oncor Inc. said it won Food and Drug Administration approval to sell its test to help breast cancer patients find out their chances of having a recurrence. The company’s Inform test is the first that analyzes genetic material to predict cancer recurrence, the company said. About 40,000 women each year are at risk for recurring breast cancer, the company said. The FDA approval comes two years after an FDA advisory panel rejected the test, saying it needed further study. Stephen Turner, the company’s founder and chief executive, said the company performed new studies and helped the FDA decipher the data on the new type of test. Shares of Gaithersburg, Md.-based Oncor rose 38 cents to close at $4.63 on the NYSE. Each test is expected to generate revenue of about $100 for the company, Turner said, while costing patients in the range of a “few hundred” dollars with office and lab fees. Potentially, 1 million tests could be performed each year in the United States alone, he said. The test is already approved in several European countries, Turner said.