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Lumicell secures FDA approval for imaging platform

Lumicell has obtained FDA approval for its LUMISIGHT optical imaging agent (NDA) and Lumicell Direct Visualization System (DVS) (PMA). Together known as LumiSystem, they aid surgeons in detecting residual cancer cells during breast cancer surgeries. The system demonstrated an 84% diagnostic accuracy in identifying cancerous tissue, potentially sparing patients from additional surgeries.

Indicated for fluorescence imaging in adult breast cancer patients, LumiSystem serves as an adjunct tool for intraoperative cancerous tissue detection within the resection cavity post-removal of the primary specimen during surgery. Safety data from over 700 breast cancer patients across five clinical studies supported the system's safety, revealing hypersensitivity reactions and urine discoloration as common side effects, with the potential for serious hypersensitivity reactions like anaphylaxis.

Efficacy was backed by results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, published in NEJM Evidence.