What is LUMISYSTEM™?
LumiSystem is the combination of two FDA approved products: LUMISIGHT™ (pegulicianine) and Lumicell™ Direct Visualization System (DVS)
LUMISIGHT is an optical imaging agent that fluoresces at sites of suspected cancerous tissue. Lumicell DVS is an imaging device that provides fluorescence guidance. This combination is used intraoperatively to illuminate breast cancer, in real-time, within the resection cavity following the removal of cancer in a lumpectomy surgery, enhancing the standard of care.
How it Works
LUMISIGHT and Lumicell DVS work together by leveraging the body's immune response to solid tumors such as breast cancer
LUMISIGHT (pegulicianine) is injected into the patient prior to lumpectomy surgery, and in just two hours it’s activated by enzymatic activity in and around the cancer. After the surgeon removes the main tumor and completes the standard of care procedure, the surgeon then inserts the Lumicell DVS handheld probe to scan inside the breast cavity where the initial tumor was removed.
In real-time, images from inside the breast cavity are captured, transferred, and read by LumiSystem’s patient-calibrated cancer detection software. When the software identifies regions that are suspicious for residual cancer, those areas are highlighted onscreen for the surgeon to see. This real-time information enables the surgeon to identify the location of additional tissue to be resected.
Supported by Clinical Evidence
LumiSystem has been clinically proven to help surgeons find cancer that would have otherwise been missed
Safety
- LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. LUMISIGHT is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.
- The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
- Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT.
Improved Surgical Outcomes
Overall, 10% of pivotal trial patients had improved surgical outcomes due to the excision of LumiSystem-guided shaves as an adjunct to standard of care lumpectomy*
35 patients with improved surgical outcomes include:
- 27 patients who had residual cancer removed
- 9 who were converted to negative margins
Note: One patient had residual cancer removed and was also converted from positive margins to final negative margins by removing LumiSystem-guided shaves; thus, the two groups combined equate to 35 patients.
* Two additional patients were converted from pathology negative margins to pathology positive margins from LumiSystem-guided shaves and underwent a second surgery.
A Breast Surgeon's Perspective
Hear from Jennifer Montes, MD, MPH, Breast Surgeon and President, Evolve Pink
Awareness and education surrounding breast cancer is key to empowering individuals to make informed decisions about their health.
Important Safety Information
What is LumiSystem™?
LumiSystem is the combination of the following FDA approved products – LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.
IMPORTANT SAFETY INFORMATION for LUMISIGHT™ and LUMICELL™ DVS
LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies.
LUMISIGHT™ (pegulicianine) Important Safety Information
What is LUMISIGHT (pegulicianine)?
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 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.
- 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 using dyes before imaging with LUMISIGHT.
What are the most common side effects of LUMISIGHT?
The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.
Lumicell™ Direct Visualization System (DVS) Important Safety Information
What is the Lumicell™ DVS?
What is the most important information I should know about 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. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
- 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 who have received LUMISIGHT.
- Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage.
- Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
- Eye discomfort: Your healthcare provider should avoid direct eye exposure to handheld light probe as it may cause pain.
