An ovarian cancer test being sold the Laboratory Corporation of America (LabCorp) was deemed to have violated the law by the US Food and Drug Administration.
The FDA said the lab assay, which claims to detect ovarian cancer at its earliest stage, needs to meet its premarketing approval requirements before it can be marketed in the US. In a letter posted on its website, the agency also said that the test called OvaSure was designed, developed, and validated by investigators at Yale University and not LabCorp.
“Our review indicates that this product is a device under section 201(h) of the Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease,” the letter 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.”
Steven I. Gutman, the director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, asked LabCorp to go through the proper channels to get approval for the ovarian cancer test.
LabCorp spokesman Eric Lindblom said the company was disappointed at receiving the letter and would issue an update about OvaSure very soon.
The test measures six proteins in blood samples and thus determines the overall risk of a woman for ovarian cancer. Previously researchers have expressed skepticism over the accuracy of the test, which was marketed for $220 from June this year.
Ovarian cancer is the eighth most common cancer among women, according to the American Cancer Society. The cancer is not discovered until it is very advanced and hence is associated with a high mortality rate. .Ovarian cancer is accountable in 3 percent of all cancers in women.
Because it is very difficult to detect the cancer during its early stages when it is best treated, women often end up going to their doctors very late in the stage when there are almost no treatment options available. That is why the new nest promised to be a life-saver.
Ovarian cancer is the fifth leading cause of cancer deaths in women. This accounts for the most number of deaths from any cause related to the female reproductive system. The ACS says that some 76 percent of women survive for one year after the ovarian cancer is diagnosed, while 45 percent have a five-year survival rate.
Surgery, chemotherapy and radiation therapy are all treatment options for ovarian cancer and doctors may recommend one or multiple courses depending on the stage of the cancer.
Ovarian cancer mainly develops in older women after menopause. The rule of the thumb is that younger women have a better chance or survival.
In a study of 224 samples, OvaSure had been able to detect ovarian cancer in 95% of the cases. The study appeared in the February 2007 issue of the journal Clinical Cancer Research. The FDA is not disputing the veracity of the test. It is however asking the company to get the requisite approval before marketing it commercially.
To read the full text of the FDA letter, visit fda.gov/foi/warning_letters/s6947c.htm