Atossa Genetics ($ATOS) said it is making headway with the FDA toward getting its signature breast cancer test back to market, a month after pulling it for not having proper clearance for its promoted use.
The Seattle startup recounted a productive "pre-510(k) submission meeting" with regulators on Nov. 14, regarding its ForeCYTE test breast pump and patient kit, coming away with enough information and confidence to at least talk about a final strategy.
"Based partially on feedback from the meeting, Atossa plans to submit a 510(k) notification to the FDA," the company explained in an announcement after the meeting. "Atossa believes that it has the data and other information to support this submission and intends to file the 510(k) with the FDA as soon as possible."
Atossa also noted in its statement that it will keep working with the FDA closely as it moves through the 510(k) process. The pump and patient kit are part of the company's ForeCYTE Breast Health test, which is is designed to find precancerous cells and cancer and also help predict the 10-year and lifetime breast cancer risk for women ages 18 to 65. A breast pump device collects fluid and then Atossa's lab uses ForeCYTE to analyze the results and determine a women's future breast cancer risk.
Executives at Atossa are working hard to regain their footing after several humbling moves by the FDA. Earlier in October, Atossa announced it had begun a voluntary recall of the test and its components in response to a February 2013 FDA warning letter that criticized the company, in part, for not having appropriate clearances for changes made to its nipple aspirate fluid specimen collection process for the breast pump portion of the test. The FDA also cited Atossa for the instructions and promotional claims it used for marketing.
At the time, Atossa explained that the pump was cleared for fluid sample collection, which could then be tested to determine if cells are cancerous, precancerous or normal. But Atossa went to great lengths to clarify that the system had not been cleared for breast cancer diagnostic screening and that ForeCYTE lacked FDA clearance or approval "for any indication."
Making matters worse, the FDA subsequently applied a Class I label to the recall--its most serious--warning that using the unapproved test could encourage a women to avoid mammography or other diagnostic options. Of particular concern: that false negatives could leave patients without a proper diagnosis or treatment and a deadly, worsening cancer.
Atossa has plenty at stake, having signed major distribution partnerships with McKesson and Thermo Fisher ($TMO). The initial furor knocked Atossa's stock price down 60% in early October. Atossa traded at around $2.30 early afternoon on Nov. 18, up 18 cents, or nearly 8.5%.
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