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Atossa Files for FDA Clearance of Recalled Breast Cancer Test

NEW YORK (GenomeWeb News) – Atossa Genetics said on Tuesday that it has submitted a premarket 510(k) notification with the US Food and Drug Administration for its ForeCYTE breast cancer test device.

The Seattle-based company voluntarily recalled the device in October after FDA voiced concerns about certain actions by Atossa, including the marketing of the device although FDA had not cleared or approved the ForeCYTE device for any indication.

At the time, Atossa also recalled its Mammary Aspiration Specimen Cytology (MASCT) Test device. MASCT was cleared by FDA for use as a sample collection device but not as a screening or diagnostic test for breast cancer.

The company met with FDA in mid-November over its plans to submit for clearance of the ForeCYTE device. The company said this week that it is seeking clearance of the ForeCYTE Breast Aspirator, which includes the ForeCYTE breast pump and patient collection kit, intended for collecting nipple aspirate fluid for laboratory cytology testing.

FDA typically has 90 days to clear the device, request additional information, or determine a device is not substantially equivalent to the predicate device, Atossa said. If FDA clears the ForeCYTE device, the firm expects to relaunch it, it added.