The FDA warned the Laboratory Corporation of America about a test, called OvaSure, that is distributed illegally. OvaSure is supposed to tell women if they have ovarian cancer at a very early stage. This test was well received by women mainly because ovarian cancer if detected early enough can be prevented from spreading outside the ovaries and becoming more dangerous. On the other hand, the Society of Gynecologic Oncologists claims that the test is not accurate enough and can manipulate women to take decisions that might be regretted later.

If ovarian cancer is detected in an early age, the ovaries are removed and the cancer has little chances to spread. OvaSure promises that it can do just that, detect the cancer in the early stage and based on this, women will remove their ovaries. If the Society of Gynecologic Oncologists is right and the test is inaccurate, OvaSure may be indeed considered a harm to public safety. The FDA addressed the Laboratory Corporation of America in a letter sent on September 29th, informing the company that its test needs government approval before it can be marketed.

One of the reasons FDA is taking action against the OvaSure test is also because it’s not being produced by LabCorp alone, the test being developed at Yale University. This is not the first time the FDA takes this kind of decision, the Food and Drug Administration also taking similar action against a colon cancer screening a year ago. The FDA is criticized because overregulation can stop medical innovation and make experiments become very expensive.