LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy.
Lumicell’s system enables real-time assessments of the breast cavity to remove residual cancer tissue. Such tissue would otherwise have been missed, according to Dr. Shelly Hwang. In a news release, Hwang, leader of Duke University’s Breast Oncology Program, said it’s “unlike any other surgical tool available” today.
The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 16-2 in favor of LumiSight. One voter abstained.
MIDAC’s decision came on the back of evidence presented by Lumicell and the FDA. It included efficacy data from over 350 patients in a pivotal study, plus safety findings from more than 700 patients across six clinical studies.
Lumicell expects the FDA to make a decision on its new drug application (NDA) and pre-market approval (PMA) submission “in the near future.”
“This MIDAC vote, supported by more than 10 years of clinical evidence, is an exciting further validation of our work,” said Jorge Ferrer, chief scientific officer, Lumicell. “We appreciate the valuable insights shared by the FDA, patients and the advisory community about the need for surgical advances in breast-conserving surgery, and we look forward to working with the FDA as it completes its review of LumiSight’s [NDA] and Lumicell DVS’ [PMA] application.”
