The FDA has told the Laboratory Corporation of America that it is illegally marketing to detect ovarian cancer at its earliest stage by a blood test. 

According to a warning letter posted Wednesday on F.D.A.’s Website, also said that the test ‘OvaSure’ was designed, developed, and validated by investigators at Yale University and not LabCorp.

The test was introduced in June and has raised hopes among women to detect ovarian cancer at an early stage. But F.D.A. said in a letter to LabCorp that the test “may harm the public health.” And the letter also added, “The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale.”

LabCorp spokesman Eric Lindblom, said, “Obviously, we are disappointed about receiving the warning letter,” but we would issue an update about Ovasure very soon, he added. The lead developer of Ovasure at Yele, Dr. Gil Mor have said the test was accurate in studies done so far. 

According to the American Cancer Society, Ovarian cancer is the eighth most common cancer among women and it is the fifth leading cause of cancer death in women. After the ovarian cancer is diagnosed 76% of women survive for one year and 45% have a five year survival rate, the ACS says. 

Ovarian cancer mainly develops in older women and the test Ovasure measure the level of six proteins in a sample of women’s blood. It calculates a probability that the women has ovarian cancer. In February 2007, in a study of 224 samples, Ovasure had been ableto detect ovarian cancer in 95% of the cases.

Now F.D.A. is asking the company to get the requisite approval before marketing it commercially.