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Wilex Reports On ODAC Meeting And Positive Vote On Diagnostic Imaging

7/25/2012 4:59 PM ET

Wilex AG reported that the U.S. Food and Drug Administration's or FDA Oncologic Drugs Advisory Committee or ODAC discussed the question: Would an imaging test provide useful clinical information if it identified only clear cell renal cell carcinoma or ccRCC within the kidney of patients with an indeterminate renal mass? ODAC voted by 16 to 0 (1 abstention) in support of the imaging information being clinically useful.

Wilex noted that after the vote the ODAC discussed to what extend the performance characteristics of the imaging test (sensitivity / specificity / reproducibility) determined in patients undergoing resection of a kidney mass providing histopathology as standard of truth could be used to estimate how the imaging agent would perform among patients who may be managed with 'active surveillance' rather than surgical resection.

Wilex said, based on the recommendation that, the company and FDA will discuss the further development strategy of its diagnostic candidate Redectane in a meeting which is planned for September 2012.

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by RTT Staff Writer

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