BREAKING NEWS: We are pleased to announce FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. To the hundreds of women and dedicated investigators who participated in this important clinical work that brought us to where we are today, THANK YOU! We wouldn’t be here without your support. 

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Revolutionary Approach to Imaging Tumor Cells Demonstrated to be Well Tolerated in First Patient Samples

Wellesley, Mass., January 6, 2016 – Lumicell, a leader in the field of image-guided cancer surgery, today announced the publication of research supporting the Company’s groundbreaking protease-activated fluorescent imaging probe, LUM015, in Science Translational Medicine. The research highlights the use of LUM015 to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human Phase I clinical trial (NCT01626066). In the research article entitled “A Mouse-Human Phase I Co-Clinical Trial of a Protease-Activated Fluorescent Probe for Imaging Cancer,” the authors highlight how the first-in-human Phase I trial showed tumor-specific fluorescence to be safe and well tolerated in humans.

Lumicell is addressing the number one challenge in cancer surgery – the need to remove all cancer cells within the tumor bed during the first surgery. In the field of cancer surgery, the goal is clean margins. Local recurrence is a common cause of treatment failure for patients with solid tumors. Intraoperative detection of microscopic residual cancer in the tumor bed could be used to decrease the risk of a positive surgical margin and could reduce rates of re-excision. The research published in Science Translational Medicine is the first study to use these probes to image human cancers.

Consistent with data from preclinical studies, when patients with STS or breast cancer were injected with LUM015 prior to surgery, the investigators found tumor tissue fluorescence measured ex vivo to be significantly higher than fluorescence measured from adjacent normal tissues. Furthermore, the study results show that the contrast between tumor and normal tissue is achieved with administration of LUM015 just a few hours before the surgery with no impact to the pre-operative workflow. Based on these results, Lumicell is currently conducting a clinical trial in breast cancer patients to compare in vivo intraoperative imaging of the tumor bed using Lumicell’s proprietary hand-held imaging device with surgical margin histopathology (NCT02438358). The imaging device has resolution capable of detecting microscopic cancer clusters as small as 100 cells in size.

“Given the very real unmet need for real-time detection of the presence of microscopic residual cancer within a tumor bed during surgery, we are pleased with this first-in-human trial and its demonstration of safety and tolerability,” said Dr. David Kirsch, Lead Investigator and Associate Professor of Radiation Oncology, Duke University Medical Center.

“As we strive to give surgeons real-time visual feedback of residual cancer in the tumor bed, our team is bolstered by our first-in-human study results,” said W. David Lee, CEO of Lumicell. “We are proud to partner with Duke University Medical Center and look forward to our continued collaborations as we drive toward the same goals in the field of image-guided cancer surgery.”

Study authors included M. J. Whitley1,2, D. M. Cardona3, A. L. Lazarides4, I. Spasojevic5,6, J. M. Ferrer7, J. Cahill8, C.L. Lee8, M. Snuderl9, D.G. Blazer III10,  S. E. Hwang10, R. A. Greenup10, P. J. Mosca10, J. K. Mito1,2, K. C. Cuneo8, N. A. Larrier8, E. K. O’Reilly11, R. F. Riedel5, W. C. Eward12, D. B. Strasfeld7, D. Fukumura9, R. K. Jain9, W. D. Lee7, L. G. Griffith13, M. G. Bawendi14, D. G. Kirsch1,8 and B. E. Brigman12.

1Department of Pharmacology and Cancer Biology, Duke University Medical Center

2Medical Science Training Program, Duke University Medical Center

3Department of Pathology, Duke University Medical Center

4School of Medicine, Duke University Medical Center

5Department of Medicine, Duke University Medical Center

6PK/PD Core Laboratory, Duke Cancer Institute, Duke University Medical Center

7Lumicell Inc.

8Department of Radiation Oncology, Duke University Medical Center

9Edwin L. Steele Laboratory, Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School

10Department of Surgery, Duke University Medical Center

11Duke Translational Medicine Institute, Regulatory Affairs Group, Duke University Medical Center

12Department of Orthopaedic Surgery, Duke University Medical Center

13Department of Biological Engineering, Massachusetts Institute of Technology

14Department of Chemistry, Massachusetts Institute of Technology

About Lumicell, Inc.

Lumicell is a leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative imaging system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable imaging agent and a novel hand-held imaging device with exquisite single-cell detection. The unprecedented ability to see and remove all cancer cells during the initial surgery has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is initially investigating its imaging system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications will include surgeries for lung, prostate, ovarian, colorectal and brain cancers. For more information, please visit

Special Notes to Reporters

More information, including a copy of the paper, can be found online at the Science Translational Medicine press package at You will need your user ID and password to access this information.

What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™, an optical imaging agent, and Lumicell™ DVS, a fluorescence imaging device. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

Indications for Use (Test)

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.


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.

LUMISIGHT™ (pegulicianine) Important Safety Information

What is LUMISIGHT (pegulicianine)?

LUMISIGHT (pegulicianine) is an optical fluorescence imaging agent 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.

Important Safety Information

  • 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?

The Lumicell™ Direct Visualization System (DVS) is for use in patients with breast cancer to help detect cancerous tissue within the lumpectomy cavity after the removal of the primary specimen during surgery. The Lumicell DVS is used with LUMISIGHT™ (pegulicianine), an imaging agent to visualize the lumpectomy cavity.

Important Safety Information

  • 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.

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.  For complete product information visit