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Home Industry News Abbott announces submission of ovarian test for FDA approval

Abbott announces submission of ovarian test for FDA approval

9th February 2010

Abbott has submitted its ARCHITECT HE4 assay for Food and Drug Administration (FDA) approval this week, it has emerged.

The device utilises a basic blood test to help monitor the recurrence or progression of epithelial ovarian cancer and if it is approved, it will represent the first automated HE4 test to become available to healthcare establishments.

A 2003 study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker.

Michael Warmuth, senior vice-president of diagnostics at Abbott, commented that the test could be a “powerful tool” in the management of the condition.

“The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care,” he added.

In other Abbott news, the firm announced this week that it has signed a contract with Pierre Fabre SA for the development of novel cancer treatments.

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