Imaging platform that illuminates residual breast cancer in real-time gets 'historic' FDA approval
A new fluorescent imaging agent capable of detecting residual breast cancer in real-time during lumpectomy surgery has just been approved by the U.S. Food and Drug Administration.
Lumicell, based in Newton, Ma, announced on Thursday the approval of Lumisight, the company’s optical imaging agent. The privately held company also shared that it had received its Premarket Approval (PMA) application for the agent’s accompanying imaging platform, the Lumicell Direct Visualization System. Together, the duo is referred to as LumiSystem.
LumiSystem enables surgeons to intraoperatively illuminate cancerous tissue in the breast cavity during lumpectomy surgery. Cancerous tissue not identified and removed during an initial lump removal surgery could require additional an operation or treatment.
In clinical trials, Lumisystem was shown to be 84% accurate at detecting residual breast cancer during an operation. It was well tolerated in most patients, though it does carry a slight risk of triggering a hypersensitivity reaction.
In a release on the news, Kelly Hunt, MD, Chair of the Department of Breast Surgical Oncology at MD Anderson Cancer Center and President of the Society of Surgical Oncology, spoke on the need to spare patients of additional surgery.
“Breast cancer is all too common, and sadly, 1 in 8 women will develop it during their lifetime. Our most common surgical procedure to treat these women is lumpectomy,” Hunt said. “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.”
Often, second surgeries are not successful in identifying the presence residual cancer, making the decisions on how to proceed in managing a patient’s diagnosis difficult, Professor of Surgery at Harvard Medical School Barbara Smith, MD, PhD, said in the same release.
“During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation,” Smith noted. “With LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery.”
Though Lumicell did not give an exact date on when the product will roll out, they did suggest on X/Twitter that they “will be available in the United States shortly."
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.