The FDA has applied its most serious label to Atossa Genetics' ($ATOS) recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.
Atossa voluntarily recalled the ForeCYTE Breast Health Test last month after a February FDA warning letter chided the company for marketing its system without agency clearance. Atossa billed its test as a tool to determine patients' cancer risk by screening small amounts of nipple aspirate fluid, but the company never secured the FDA's backing for those claims.
Now, the agency has applied a Class I label to the recall, warning that using ForeCYTE as a stand-in for mammography or other diagnostic procedures could put patients at serious risk. False positives could spur needless anxiety and unnecessary medical costs, the FDA said, while false negatives could lead to delayed diagnosis and treatment of breast cancer, increasing chances of death.
Atossa has said it's working with the FDA to get its banner product back on the market, but it may be difficult to reverse the damage, and the company's shares have fallen roughly 60% since October. The recall came amid Atossa's nationwide commercial scale-up for ForeCYTE, following partnerships with distribution giants McKesson and Thermo Fisher ($TMO) to spread the system around the country. The company believed its test had a chance to become as ubiquitous as the Pap smear, CEO Steven Quay said.
Atossa has said it hasn't heard of any adverse events tied to ForeCYTE, and the FDA is asking patients and physicians to report problems through its MedWatch platform.
Source: FDA
Atossa voluntarily recalled the ForeCYTE Breast Health Test last month after a February FDA warning letter chided the company for marketing its system without agency clearance. Atossa billed its test as a tool to determine patients' cancer risk by screening small amounts of nipple aspirate fluid, but the company never secured the FDA's backing for those claims.
Now, the agency has applied a Class I label to the recall, warning that using ForeCYTE as a stand-in for mammography or other diagnostic procedures could put patients at serious risk. False positives could spur needless anxiety and unnecessary medical costs, the FDA said, while false negatives could lead to delayed diagnosis and treatment of breast cancer, increasing chances of death.
Atossa has said it's working with the FDA to get its banner product back on the market, but it may be difficult to reverse the damage, and the company's shares have fallen roughly 60% since October. The recall came amid Atossa's nationwide commercial scale-up for ForeCYTE, following partnerships with distribution giants McKesson and Thermo Fisher ($TMO) to spread the system around the country. The company believed its test had a chance to become as ubiquitous as the Pap smear, CEO Steven Quay said.
Atossa has said it hasn't heard of any adverse events tied to ForeCYTE, and the FDA is asking patients and physicians to report problems through its MedWatch platform.
Source: FDA
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