The U.S. Food and Drug Administration (FDA) have issued a warning letter to Laboratory Corporation of America, also known as LabCorp, for illegally marketing a drug test to detect ovarian cancer.
First introduced in June, the test promises to detect ovarian cancer in early stages, when the disease is still treatable.
The Society of Gynecologic Oncologists along with other outside experts, say the test has not been proven accurate and may lead women to undergo unnecessary ovary removal surgery.
The FDA, in an earlier letter to LabCorp, said the test “may harm public health.”
In the most recent letter, sent September 29, the FDA said the test, called OvaSure, required agency approval before it could be marketed.
The agency determined that the OvaSure test was designed, developed and validated by researchers at Yale University and not that of LabCorp. Instructions for use and performance appear to have been developed by Yale researchers.
Additionally, the materials used to produce the test are manufactured and based on specifications made by Yale. Therefore, the device is not within the scope of laboratory developed tests over which the agency traditionally exercises enforcement discretion.
The agency’s review indicates the product is a device under section 201(h) of the Food, Drug and Cosmetic Act, because it is intended for use in the diagnosis if disease or other health conditions, or in the cure, treatment, prevention or mitigation of disease.
Dr. Gil Mor, lead developer of OvaSure at Yale and LabCorp has said tests conducted thus far have been accurate.
The OvaSure test uses a sample of blood to measure the level of six proteins in the woman’s blood and calculates the likelihood of ovarian cancer.
Ovarian cancer remains the most deadly cancer of the female reproductive system. About 20 percent are found in an early stage. When found early, about 94 percent of women live longer than five years after diagnosis.
The American Cancer Society (ACS) reports more than 22,000 new cases will be diagnosed this year. More than 15,000 women die from ovarian cancer every year according to the ACS.
A previous study found adding a blood test to the "symptom index" for ovarian cancer, can lead to earlier and more accurate detection of the “silent killer.”
Symptoms of ovarian cancer are often subtle, but most women knew something was wrong before they were diagnosed. Adding a blood test to look for a tumor marker, can increase detection to 80 percent. #