Sam Brusco, Associate Editor04.19.24
Lumicell has gained U.S. Food and Drug Administration (FDA) approval for its LUMISIGHT optical imaging agent and Lumicell Direct Visualization System (DVS). Together, they are dubbed LumiSystem.
LumiSystem allows scanning the breast cavity post-lumpectomy in real-time to detect and resect residual cancer that may have otherwise been missed. The LumiSystem combo is indicated for fluorescence imaging in adult patients with breast cancer, as an adjunct for intraoperative detection of cancerous tissue in the resection cavity after removing the primary specimen during lumpectomy.
Lumicell said the LumiSystem exhibits 84% diagnostic accuracy. The system’s safety was established with data from over 700 breast cancer patients in five U.S. clinical studies. The most common side effects reported with LUMISIGHT were hypersensitivity and abnormal urine color—the company advised it may cause serious hypersensitivity reactions, including anaphylaxis.
The results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, which were used to support the system’s efficacy, were published in NEJM Evidence.
Barbara Smith, MD, Ph.D., Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, said that during lumpectomy surgery, surgeons still struggle with identifying and removing all of the tumor during the first operation.
“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,” Dr. Smith told the press.
“We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS—we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA's most stringent NDA and PMA review processes,” said Lumicell president and chief operating officer Howard Hechler. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.”
Lumicell’s LUMISIGHT optical imaging agent is also being explored for more development across a variety of solid tumor indications.
LumiSystem allows scanning the breast cavity post-lumpectomy in real-time to detect and resect residual cancer that may have otherwise been missed. The LumiSystem combo is indicated for fluorescence imaging in adult patients with breast cancer, as an adjunct for intraoperative detection of cancerous tissue in the resection cavity after removing the primary specimen during lumpectomy.
Lumicell said the LumiSystem exhibits 84% diagnostic accuracy. The system’s safety was established with data from over 700 breast cancer patients in five U.S. clinical studies. The most common side effects reported with LUMISIGHT were hypersensitivity and abnormal urine color—the company advised it may cause serious hypersensitivity reactions, including anaphylaxis.
The results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, which were used to support the system’s efficacy, were published in NEJM Evidence.
Barbara Smith, MD, Ph.D., Director of the Breast Program at Massachusetts General Hospital and Professor of Surgery at Harvard Medical School, said that during lumpectomy surgery, surgeons still struggle with identifying and removing all of the tumor during the first operation.
“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,” Dr. Smith told the press.
“We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS—we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA's most stringent NDA and PMA review processes,” said Lumicell president and chief operating officer Howard Hechler. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.”
Lumicell’s LUMISIGHT optical imaging agent is also being explored for more development across a variety of solid tumor indications.