On December 3, 2008, the Immunology Devices Advisory Panel met to provide recommendations to the U.S. Food and Drug Administration (FDA) on issues relevant to granting 510(k) clearance to the Fujirebio HE4 Enzyme Immunoassay and Risk of Ovarian Malignancy Algorithm™. The panel provided recommendations on FDA questions about the appropriateness of the study design and intended use population; whether the test performance characteristics are consistent with safe and effective use of the test in selecting low risk women for whom surgical intervention performed by a non-oncology specialists is appropriate; whether test results can be knowledgably and safely integrated with other clinicopathologic information; how the clinical impact of false positive or false negative results might vary according to the underlying disease; whether intra-operative conversion from non-oncology to oncology operative procedures would be practical and safe; whether special measures are needed to ensure correct determination of menopausal status.
Six speakers addressed the panel in the Open Public Hearing sessions, including practicing gynecologic oncologists, a representative from an ovarian cancer advocacy organization and an ovarian cancer survivor.
The panel aired many considerations about the intended use population and the likely impact of the test in clinical practice, especially concerning use of the test to determine whether patients might be appropriately referred for treatment in a non-oncology treatment setting. There were suggestions both concerning modification of the intended use to align better with safety and effectiveness and concerning the need for additional data in order to establish safety and effectiveness.
The panel made recommendations to modify the proposed indication for use, suggesting the device should be used as clinical information tool, not used for triage of patients who have been referred to the gynecologic oncologist back to general gynecologic surgeon for treatment. It was also suggested that additional data for the safe and effective use of the device in community hospital settings may be needed.
The panel concluded that additional data would be needed in order to understand how the test results can be knowledgably and safely integrated with other clinicopathologic information. It further concluded that false negative test results pose little risk for some ovarian tumors with low malignant potential. There were mixed opinions concerning practicality and safety for intra-operative conversion of surgical procedures. There was consensus that methods for assessing menopausal status, as widely used, are generally sufficient for use with the new test.
The meeting adjourned, having considered all of the questions posed by FDA.
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