FDA approves Lumicell’s breast cancer imaging tool

Lumisystem comprises two integral components: Lumisight and Lumicell DVS. Lumisight is a molecular entity sensitive to enzymes predominantly present in and around tumor cells, emitting a fluorescent signal upon interaction. On the other hand, Lumicell DVS incorporates a handheld probe and a tumor detection algorithm, aiding surgeons in cavity illumination and real-time image analysis and display.

The FDA has greenlit Lumisight via a new drug application and granted Lumicell DVS premarket approval. This enables surgeons to utilize both components concurrently for fluorescence imaging in adult patients with breast cancer. Lumicell obtained authorization based on data from a prospective clinical trial involving approximately 400 patients. The trial, which compared standard care with Lumicell imaging, achieved predetermined criteria for residual tumor removal and specificity but fell short of sensitivity targets.

The mixed trial outcomes influenced the FDA advisory panel's decision. While Lumisight garnered support in a 16-2 vote, some endorsements for the imaging agent were accompanied by stipulations.