Oncor preparing for clinical trials of p43 early-stage breast cancer test.
This article was originally published in The Gray Sheet
Executive Summary
ONCOR PMA FOR p43 EARLY-STAGE BREAST CANCER DETECTION TEST is slated for submission to FDA in 12-18 months, the company says. The premarket approval application likely will be supported by data from an upcoming four-center clinical trial. However, Oncor also is examining the possibility of a PMA based on retrospective data with prospective data gathered after approval. The company is working with FDA to design the four-site study, which will be led by researchers from the Albany Medical Center, New York.