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Abbott New Ovarian Cancer Test Wins FDA Clearance

Abbott's Architect HE4 (human epididymis protein 4) assay, a new diagnostic test to monitor ovarian cancer, has received FDA clearance. It is an automated test available in the US which uses a simple blood test to aid in monitoring for the recurrence or progression of ovarian cancer.

Abbott has partnered with Fujirebio Diagnostics in the development of the assay. The Architect HE4 assay is also approved for use in Europe, as well as in other countries in Asia Pacific and Latin America.

Architect HE4 assay is a chemiluminescent microparticle immunoassay for the quantitative determination of HE4 antigen in human serum. The assay is designed to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and should be used in conjunction with other clinical data.

The current test, mainly used to monitor ovarian cancer, CA125, measures levels of a protein in the blood as an indication of a possible recurrence or disease progression in ovarian cancer patients.

While 80% of ovarian cancers express CA125, 20% of all ovarian cancers do not. By using Abbott’s new HE4 test in conjunction with other clinical methods, including CA125, physicians are expected to get clear clinical picture when monitoring ovarian cancer patients.

Abbott said that the Architect HE4 assay 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.

John Coulter, divisional vice president, US commercial operations at Abbott Diagnostics, said: “Abbott remains committed to finding more efficient and cost-effective ways to aid in the detection and monitoring of cancer. With the FDA clearance of the Architect HE4 assay, we are able to provide physicians with a test that will help guide important patient care decisions with a high level of consistency, reliability and affordability.”

Richard Moore at Women and Infants Hospital, Brown University, said: “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. 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.”