New Diagnostic Monitors Patients for Epithelial Ovarian Cancer

HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any marker and is considered the best single marker for stage 1 of the disease.

Abbott (Abbott Park, IL, USA) partnered with Fujirebio Diagnostics, Inc. (Malvern, PA, USA) in the development of the immunoassay. The Architect HE4 assay is approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the United States. Abbott has submitted the new automated ovarian cancer test for 510(k) clearance by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46 %. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93 %. Less than 20 % of all ovarian cancer is found in the early stage.

The Architect HE4 assay must be used in conjunction with other clinical data. It should not be used as a cancer-screening test. In addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely express HE4, and the use of the Architect HE4 assay is not recommended for monitoring patients with those types of cancer.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture, and marketing of medical products, including nutritionals, devices, diagnostics, and of pharmaceuticals.

Related Links:
Abbott
Fujirebio Diagnostics, Inc.
US Food and Drug Administration
American Cancer Society