Lumicell Unveils New CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment

Lumicell Inc., a private company based in Newton, Massachusetts, has announced a significant development in the field of cancer detection technology. The American Medical Association (AMA) has awarded a Category III, Current Procedural Terminology (CPT) add-on code 0945T for intraoperative fluorescence imaging margin assessment following breast cancer lumpectomy. This new code, effective from January 1, 2025, aims to streamline the reporting of medical, diagnostic, and testing services, facilitating clear communication among healthcare providers, patients, and payors.

Howard Hechler, President and COO of Lumicell, highlighted the importance of this milestone, noting that the new CPT code will enable physicians to report their use of the LumiSystem, comprising LUMISIGHT™ and Lumicell™ DVS, to collect claims data. This data collection is crucial for improving access and potentially securing future reimbursement from both government and commercial health insurance providers in the United States.

Clinical studies underscore the importance of accurate margin assessment during lumpectomy procedures. Up to 36% of patients require additional surgeries due to positive margins, and 14% of those with negative margins still have residual cancer. The LumiSystem, with an 84% diagnostic accuracy rate, is the first system that allows surgeons to scan the breast cavity in real-time, detecting and resecting residual cancerous tissue that might otherwise go unnoticed.

Dr. Peter Blumencranz, Medical Director of BayCare Oncology Service Line and The Comprehensive Breast Care Center of Tampa Bay, emphasized the positive impact the new CPT code will have on patient access to LumiSystem, potentially leading to better surgical outcomes for breast cancer patients.

Lumicell's lead products, LUMISIGHT™ (pegulicianine) and Lumicell™ DVS, are designed to work together during lumpectomy procedures. LUMISIGHT acts as an optical imaging agent, and Lumicell DVS is a fluorescence imaging device. These products aim to illuminate cancerous tissue within the breast cavity, assisting surgeons in achieving a more complete resection of cancerous tissues. The company is also exploring the use of LUMISIGHT for various other solid tumor indications.

The safety profile of LUMISIGHT and Lumicell DVS is important for healthcare providers to consider. LUMISIGHT may cause hypersensitivity reactions, including anaphylaxis, and healthcare providers are advised to have emergency resuscitation equipment and trained personnel readily available. Additionally, both the absence and presence of a fluorescence signal do not definitively rule out cancer, and misdiagnosis can occur. Lumicell DVS, used as an adjunct to standard procedures, requires proper training to avoid tissue damage or infection.

Lumicell is set to make the LumiSystem commercially available in the fourth quarter of this year. The company continues to focus on advancing fluorescence-guided surgery technology to improve the completeness of cancer resections. For more information about Lumicell and its products, visit their official website.

In summary, the AMA's granting of the new CPT code marks a significant advancement for Lumicell, potentially enhancing the adoption and reimbursement of their innovative cancer detection technology. This development could lead to improved surgical outcomes for breast cancer patients by enabling more precise and thorough removal of cancerous tissues during lumpectomy procedures.