ARTICLE | Regulation

Redectane redirect

Wilex, FDA disagree on when to do outcomes study of cancer diagnostic

June 27, 2011 7:00 AM UTC

Wilex AG and FDA are in agreement that the next logical step for the biotech's Redectane kidney cancer diagnostic is a clinical outcomes study. But so far, they differ on whether the study should be done pre- or postmarket.

The company is developing Redectane as an antibody-based diagnostic imaging agent for the pre-surgical detection of clear cell RCC in combination with CT, ultrasound or bone scan...