BioCentury
ARTICLE | Company News

Atossa Genetics sales and marketing update

October 7, 2013 7:00 AM UTC

Atossa is recalling its Mammary Aspirate Specimen Cytology Test (MASCT) device and the accompanying ForeCYTE Breast Health Test. The device is cleared for use only as a device to non-invasively collect samples of breast fluid. The specimens are analyzed at Atossa's CLIA-certified laboratory using ForeCYTE, a laboratory-developed test that Atossa uses to differentiate between normal, premalignant and malignant tumor cells. ForeCYTE has not been cleared by FDA for any indication. According to Atossa, FDA is concerned the products are being used to screen or diagnose breast cancer as a substitute for mammograms and biopsies.

In February, the company received a warning letter from the agency citing issues with the instructions for use of the products as well as concerns about the promotional claims used to market the devices. Atossa said it is working with FDA to address the agency's concerns, but the company did not provide a timeline on when it expects the products will be available again. ...