by Jim Adler
The FDA isn’t always the most reliable watchdog of the public health. Too many defective drugs have had its approval. But in this case the Food and Drug Administration appears on target with its caution.
It seems some manufacturers of what’s known as nipple aspirate tests have claimed their home-administered tests are stand-alone alternatives to a biopsy or mammography in detecting the presence or absence of breast cancer.
Not so fast, the FDA says in a new alert.
These pumps — which collect fluid to assess if it contains abnormal cells — are not necessarily capable of what their manufacturers claim, the FDA says. In fact, the National Comprehensive Cancer Network says such tests’ clinical utility is still being evaluated, and they should not be deemed a screening technique for breast cancer.
The FDA says any claims to the contrary are misleading. Thus, biopsies or breast imaging tests such as mammograms remain necessary to diagnose and screen for breast cancer.
If women fail to heed this alert, the FDA says, they could be subject to false negative test results showing no breast cancer when in fact it exists, or false positive test results showing breast cancer exists when it doesn’t.
Such incorrect tests could delay proper diagnosis and treatment, thus threatening a woman’s health — and even her life.