One in eight U.S. women will be diagnosed with breast cancer during their lifetime, and many of these patients will undergo a lumpectomy, a surgical treatment to remove the tumor while preserving as much healthy breast tissue as possible.
Despite surgical advancements, up to 36% of patients require a second lumpectomy because cancer may have gone undetected.1 However, when these second surgeries are performed, cancer is not found in up to 65% of cases.1 This leaves patients and surgeons uncertain about the possibility of cancer remaining in the breast. Uncertainty persists even for patients who receive a report of negative margins following the initial surgery, with approximately 14% of them possibly still having cancer remaining.1
LumiSystem™ represents a promising advancement in surgical imaging technology that can be added to the lumpectomy procedure. Clinically proven to detect cancer that otherwise would have been missed, LumiSystem helps reduce the need for follow-up surgeries by detecting residual cancer in real-time. This capability not only spares some patients from additional procedures, but also may inform the surgeon of the presence of cancer not initially detected.
LumiSystem is the combination of two recently FDA-approved products: LUMISIGHT™ (pegulicianine), an optical imaging agent that fluoresces at sites of suspected cancerous tissue, and Lumicell™ Direct Visualization System (DVS), an imaging device that provides fluorescence guidance, enabling surgeons to do real-time scanning of the breast cavity during lumpectomy to detect and resect residual cancer that may have otherwise been missed.
“During initial lumpectomy surgeries, surgeons still struggle to identify and remove all of the tumor,” says Barbara Smith, M.D., Ph.D., director of the Breast Program at Massachusetts General Hospital, professor of surgery at Harvard Medical School, and an investigator in the LumiSystem clinical study. “With LumiSystem, we now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy, which could help some patients avoid a second surgery.”
In clinical trials, use of LumiSystem removed tumors that would have been missed by standard surgery with 84% diagnostic accuracy and helped some patients avoid a second surgery.2 Results from the LumiSystem clinical study showed that 10% (35/357) of women had improved surgical outcomes when using LumiSystem as a part of their lumpectomy procedure. (Of the 35 patients with improved surgical outcomes, LumiSystem detected and guided the removal of cancer that would have been missed otherwise in 27 patients. Nine patients experienced a conversion from positive to negative margins and one patient experienced both instances.)2
Howard Hechler
Chief Executive Officer, Lumicell
“Innovation in the operating room is long overdue, given the pace of advancements in breast cancer detection and treatment,” said Howard Hechler, Chief Executive Officer of Lumicell. “We are proud to lead the way in image-guided cancer surgery with the U.S. launch of LumiSystem, the first and only imaging combination product approved for detecting cancerous tissue where and when it matters most, inside the breast cavity during lumpectomy.”
To learn more about advances in breast cancer surgery, visit www.LumiSystem.com
IMPORTANT SAFETY INFORMATION
What is LUMISIGHT (pegulicianine) and Lumicell DVS?
• LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.
What is the most important information I should know about LUMISIGHT?
• Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during the use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.
• The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
What additional important information should I know about LUMISIGHT and Lumicell DVS?
• Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology.
• Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
• Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
• Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information visit www.LumiSystem.com.
Rx only
References
- Dupont, et al. Ann Surg 2021.
- Smith, et al.,NEJM Evidence 2023; 2(7)
MKT00316rA
