FDA Approves New Imaging for Breast Cancer Detection After Lumpectomy

In a significant development for breast cancer patients, a new tool has emerged that could revolutionize the way surgeons ensure thoroughness during lumpectomy procedures.

The FDA has greenlit the LumiSystem, comprising the LUMISIGHT (pegulicianine) optical imaging agent and the Lumicell Direct Visualization System (DVS). This innovative system boasts an impressive 84% diagnostic accuracy, allowing surgeons to conduct real-time scans of the breast cavity post-lumpectomy.

Its purpose? To pinpoint and excise any residual cancer that might have eluded detection, potentially sparing patients the ordeal of additional surgeries.

The pivotal INSITE trial, published in NEJM Evidence, provided the foundation for LumiSystem's efficacy claims, specifically targeting adult patients with breast cancer as an intraoperative adjunct for detecting cancerous tissue post-resection.

The safety profile of LUMISIGHT draws from data across various clinical studies involving over 700 breast cancer patients, with common side effects such as hypersensitivity and changes in urine color. Notably, serious hypersensitivity reactions, including anaphylaxis, are possible.

Howard Hechler, Lumicell's president and COO, said in a company press releases that the significance of LumiSystem's FDA approval as a drug-device combination product, marking a substantial milestone in medical advancements focused on detecting cancerous tissue within the breast cavity.