The FDA has asked Atossa Genetics to provide additional information on the ForeCYTE breast aspirator before it decides whether to clear the product for marketing, the Seattle devicemaker revealed Tuesday.
In October, Atossa recalled the breast cancer screening test, which extracts fluid from the nipple for cytological testing, after the FDA cited it for making design changes without obtaining proper clearance. The company responded in December by submitting a 510(k) notification for both the ForeCYTE breast pump and patient collection kit.
The company’s 510(k) submission came as the FDA warned Americans that breast aspiration is not a suitable alternative to mammography in breast cancer screening.
Atossa said it will seek an extension to the 30-day time frame for responding to requests for information. If approved, the company would have 150 more days to provide the information, bringing the total to 180 days.
Atossa is currently developing additional breast cancer screening tests: the FullCYTE for women identified as being at high risk of breast cancer, the ArgusCYTE for women with a prior diagnosis and the NextCYTE to predict treatment outcomes and recurrence. —Lena Freund
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