Wilex AG reported that the U.S. Food and Drug Administration's or FDAOncologic Drugs Advisory Committee or ODAC discussed the question: Would animaging test provide useful clinical information if it identified onlyclear cell renal cell carcinoma or ccRCC within the kidney of patients withan indeterminate renal mass? ODAC voted by 16 to 0 (1 abstention) insupport 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 kidneymass providing histopathology as standard of truth could be used toestimate how the imaging agent would perform among patients who may bemanaged 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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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.