Seattle company’s breast cancer test pulled from stores

A Seattle company that makes a test for early warning of breast cancer risk is pulling its products from the market.

The voluntary recall includes products and devices associated with the ForeCYTE test sold by Atossa Genetics. Company CEO, Dr. Steven Quay, said last month that the test, which collects fluid from the breast for laboratory analysis, is about cancer prevention, not detection. “It’s to find the cause of breast cancer, not breast cancer itself.” The test targets women in their 20s and 30s.

In a statement Friday, Quay said the recall is to address concerns raised by the Food and Drug Administration in a warning letter, including certain instructions, promotional claims and changes made to one device.

The company said it will remove its products from the market until the government regulators’ concerns are resolved.

Atossa stock was down more than 40 percent on the news.