One in eight U.S. women will be diagnosed with breast cancer during their lifetime, with many undergoing a lumpectomy to remove the tumor while preserving healthy breast tissue. The LumiSystem, combining LUMISIGHT (pegulicianine) and Lumicell DVS, introduces a promising advancement in surgical imaging technology. It is clinically proven to detect cancer that might otherwise be missed, thereby reducing the need for follow-up surgeries by identifying residual cancer in real-time.
Barbara Smith, M.D., Ph.D., from Massachusetts General Hospital, highlights the struggle surgeons face in identifying and removing all of the tumor during initial lumpectomy surgeries. The LumiSystem offers a technology that has been clinically proven to achieve a more complete cancer resection, potentially helping patients avoid a second surgery.
Clinical trials have demonstrated that the use of LumiSystem removed tumors that standard surgery would have missed, with an 84% diagnostic accuracy. It has also helped some patients avoid a second surgery, with 10% of women experiencing improved surgical outcomes when LumiSystem was part of their lumpectomy procedure.
Howard Hechler, CEO of Lumicell, emphasizes the importance of innovation in the operating room, given the advancements in breast cancer detection and treatment. The U.S. launch of LumiSystem marks a significant step forward in image-guided cancer surgery, being the first and only imaging combination product approved for detecting cancerous tissue inside the breast cavity during lumpectomy.
LUMISIGHT and Lumicell DVS are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following the removal of the primary specimen during a lumpectomy procedure. However, it's important to note that LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis, and healthcare providers should be prepared to manage such reactions. The most common side effects include hypersensitivity and an abnormal color in urine.
Lumicell DVS is intended for adjunctive use as part of the lumpectomy procedure and does not replace standard care procedures and pathology. There is a risk of misdiagnosis, as the absence of a signal does not rule out cancer, and a positive signal may be seen in non-cancerous tissue. Additionally, healthcare providers should avoid using dyes for sentinel lymph node mapping before imaging the lumpectomy cavity in patients who have received LUMISIGHT. Using the Lumicell DVS handheld probe may also cause tissue damage or infection.
