The FDA is warning consumers to avoid using nipple aspirate diagnostic tests instead of mammography to help spot breast cancer, a move that expands on its recent crackdown against Atossa Genetics ($ATOS) for allegedly making misleading claims to patients about what the test can accomplish.
Regulators issued a Dec. 12 safety communication to make the case that "a nipple aspirate test is not a replacement for mammography, other breast imaging tests or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer."
The alert names Seattle-based Atossa Genetics and Irvine, CA-based Halo Healthcare as two of the makers of nipple aspirate tests. FDA officials also note that "certain manufacturers" are promoting the tests as a "stand-alone evaluation tool" to help screen for and diagnose breast cancer, even though their usefulness as a separate diagnostic is still under evaluation.
Regulators detail in the safety communication the action they've taken so far against Atossa, including a February 2013 warning letter and a subsequent Class I recall designation in November (indicating risk of serious health problems or death) for both Atossa's ForeCYTE Breast Health Test and its Mammary Aspiration Specimen Cytology Test (MASCT), alleging they were marketed for unapproved cancer diagnostic uses.
Atossa acknowledged in its recall over the fall that MASCT is cleared for fluid sample collection, after which the fluid can be used to determine if cells are normal, precancerous or cancer. But there's an important distinction: It isn't yet cleared for breast cancer screening. Additionally, Atossa admitted in its recall that ForeCYTE lacked approval yet for any indication. It's designed to screen for precancerous cells and cancer, and also to help predict the 10-year and lifetime breast cancer risk for women ages 18 to 65. The tests work together: MASCT collects the breast fluid noninvasively and then Atossa's lab uses ForeCyte to analyze the results and calculate a woman's future breast cancer risk.
Atossa has pledged to work with the FDA to get its signature breast cancer test back to market, and last month recounted a productive "pre-510(k) submission meeting" with regulators in mid-November.
Halo's similar Halo Breast Pap test remains on the market, MedPage Today noted.
The FDA recommends that patients who had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer should request a mammogram. Regulators said they will continue to monitor how nipple aspirate test manufacturers promote their products.