Zila’s OraTest Oral Cancer Screen Lags At CDER; ZTC Clears Premarket Hurdle
This article was originally published in The Pink Sheet Daily
Executive Summary
Zila Medical bypasses lengthy CDER regulatory path, gains 510(k) clearance for ZTC tolonium chloride compound at CDRH. Oral cancer test’s identical compound, OraTest, remains under CDER review.