ForeCYTE Breast Aspirator regulatory update

Atossa submitted information in response to a request from FDA related to the company's 510(k) application for the ForeCYTE Breast Aspirator for use in the collection of nipple aspirate fluid for laboratory cytological testing. The company said the response included data from a single-arm clinical trial in adult women using ForeCYTE for the collection, fixation, transport and processing of nipple aspirate fluid specimens for laboratory cytological testing. The response also included data from a study of positive and negative control reference panel specimens with a blinded cytological interpretation when the specimens were processed and read at multiple, independent laboratories; and data to establish shelf life information and document shipping stability under adverse conditions of ForeCYTE.

FDA requested the information in February as part of the agency's review of the application (see BioCentury, March 10). Atossa declined to comment on when it expects FDA to finalize the review process, which may include requests for additional information. ...