Lumisystem has two components called Lumisight and Lumicell DVS. Lumisight is a molecule that reacts to enzymes found at higher levels in and near tumor cells. The reaction produces a fluorescent signal. The other component features a handheld probe and a tumor detection algorithm that the surgeon uses to illuminate the cavity and analyze and display images in real time.

The FDA approved the new drug application for Lumisight and granted premarket approval to Lumicell DVS. Surgeons can now use the drug and device components together for fluorescence imaging in adults with breast cancer.

“Our most common surgical procedure to treat these women is lumpectomy,” Kelly Hunt, chair of the department of breast surgical oncology at MD Anderson Cancer Center, said in a statement. “Unfortunately, the intraoperative tools we have are limited and do not identify the extent of tumor accurately enough, making it challenging to achieve a complete tumor resection, leading to as many as 36% of patients needing a second surgery.”

Lumicell secured the authorization using data from a prospective clinical trial that randomized about 400 patients to receive standard of care or undergo imaging using the Lumicell device. The study met prespecified thresholds for removal of residual tumor and specificity but fell short of the sensitivity goal.

The mixed result informed the FDA’s advisory panel. While the panel backed Lumisight in a 16-2 vote, some support for the imaging agent came with caveats. One panelist voted yes because the “incremental benefits outweigh the small risks of anaphylaxis.” Another expert who voted yes said the tool fell short of the hoped-for “end game” of no positive margins.