In a major setback, Atossa Genetics ($ATOS) is pulling its signature breast cancer test and related products from the market to address the FDA's allegations that they lacked clearance for their promoted uses.
Atossa's action comes almost a year after it went public to raise money for a national rollout of the ForeCYTE Breast Health test, which is designed to spot early signs of breast cancer and predict future risk.
The promising Seattle startup acknowledged it has begun a voluntary recall of ForeCYTE, as well as its Mammary Aspiration Specimen Cytology Test (MASCT) device (plus the MASCT System Kit and Patient Sample Kit). Both actions stem from a February 2013 FDA warning letter to the company. Execs are urging distributors and customers to stop using both products and return them. Atossa, which launched in 2009, emphasized that it hasn't heard about any adverse patient problems relating to the products, but cautioned that both products could produce false positive or false negative results, even as they lack appropriate clearances for diagnostic use. They'll stay off the market until Atossa addresses all the various FDA issues, the company said.
The FDA's warning letter slammed Atossa over its instructions for use, some promotional claims it used for marketing and for not having appropriate clearances for changes made to its nipple aspirate fluid specimen collection process for the MASCT breast pump.
Atossa notes in its recall announcement that MASCT is cleared for fluid sample collection, after which the fluid can be used to determine if cells are normal, precancerous or outright cancer. But the company explains the device hasn't been cleared for breast cancer screening. Sounding contrite, the company also noted that ForeCYTE doesn't have FDA clearance or approval yet "for any indication." The FDA's big worry here is that patients could use both products as a substitute for recommended breast cancer diagnostics or screening and not proceed with the mammograms or biopsies they need.
ForeCYTE is designed to find precancerous cells and cancer, and help predict the 10-year and lifetime breast cancer risk for women ages 18 to 65. MASCT collects breast fluid noninvasively and then Atossa's lab uses ForeCyte to analyze the results and determine a woman's breast cancer risk in the future.
Just a few weeks ago, Atossa inked a big national distribution deal with McKesson Medical-Surgical to sell MASCT, building on a similar agreement signed with Thermo Fisher ($TMO) earlier in the summer. In January, Atossa disclosed it was training as many as 5,000 independent sales representatives to market ForeCYTE.
- read the company's announcement
- here's the FDA's warning letter