HE4 TEST FOR OVARIAN CANCER APPROVED

June 14, 2010 — The US Food and Drug Administration (FDA) has cleared a chemiluminescent microparticle immunoassay (Architect human epididymis protein 4 [HE4] assay; Abbott Diagnostics) for the quantitative determination of HE4 antigen, an ovarian cancer marker, in serum samples.

HE4 measurements are intended for use in combination with other clinical data to monitor recurrence or progression of epithelial ovarian cancer. Epithelial ovarian cancer is the most common form of the ovarian cancer, which affects an estimated 1 of every 71 women in the United States during their lifetimes.

"Disease monitoring in ovarian cancer is crucial. Seventy-five percent of all ovarian cancer patients will have a recurrence," said Cara Tenenbaum, vice president of policy and external affairs, Ovarian Cancer National Alliance, in a company news release. "New monitoring tools may provide patients and physicians with critical disease information to help make important treatment and care decisions."

The current gold standard for monitoring ovarian cancer consists of monitoring serum levels of the protein CA125, a biomarker that is only expressed by 80% of tumors. As previously reported by Medscape Hematology-Oncology, clinical data suggest that HE4 has the highest sensitivity and specificity of any marker, including CA125, for detecting malignancy.

"HE4 is an excellent marker for monitoring women diagnosed with ovarian cancer, especially in those patients where CA125 is not a marker for their disease," noted Richard Moore, MD, from the Women and Infants Hospital, Brown University, Providence, Rhode Island, in the news release. "The addition of HE4 to monitor recurrence or progressive epithelial cancer is an important advance in ovarian cancer care and will provide us with the best information available today."

Study data also suggest that HE4 is the best single marker for detecting stage 1 disease. Testing for both the CA125 and HE4 biomarkers could potentially improve the detection of ovarian cancer, particularly in its early stages, when treatment is most effective. Although diagnosis and treatment of ovarian cancer before metastasis can increase the 5-year survival rate from 46% to 96%, less than 20% of cancers are currently found at this early stage.

The HE4 assay was developed in partnership with Fujirebio Diagnostics, Inc, and previously was approved for use in the European Union, as well as countries in Asia Pacific and Latin America.