Lumicell has received approval for its new drug application (NDA) for LUMISIGHT optical imaging agent and premarket approval (PMA) application for Lumicell direct visualisation system (DVS) from the US Food and Drug Administration (FDA).
The LUMISIGHT optical imaging agent and Lumicell DVS are together referred to as LumiSystem, which aims to assist surgeons in detecting residual cancer cells during breast cancer surgeries.
Lumicell said the LumiSystem demonstrated an 84% diagnostic accuracy in identifying cancerous tissue that might have been missed during lumpectomy surgery and sparing some patients from second surgeries.
