Oncor study of bladder cancer microsatellite DNA test to begin in several months.
This article was originally published in The Gray Sheet
Executive Summary
ONCOR PMA FOR BLADDER CANCER MICROSATELLITE DNA TEST may be submitted as early as 1997 but more likely will not be ready until 1998 due to the pursuit of a patient screening indication for the test, the Gaithersburg, Maryland company says. Oncor is hoping to pursue approval of the test for screening in high-risk populations, which would require more extensive follow-up data than a patient monitoring claim, the company says. However, the test is still in early stages of development, Oncor notes, and the final form of the premarket approval application has yet to be determined.