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The FDA approved pegulicianine (LumiSight) as an optical imaging agent for detecting residual cancer after breast-conserving surgery (BCS).

The stipulates use of pegulicianine with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device approved for use with pegulicianine. The fluorescent dye is administered intravenously before surgery. Then after the tumor is removed, the hand-held probe device is used to scan the lumpectomy cavity. Image analysis software show fluorescence where any residual cancer is detected.

Currently available intraoperative tools frequently do not identify the full extent of a breast tumor, leading to for as many as 36% of patients who undergo BCS.

"Up to 65% of the time, we do not find residual cancer in the second surgery and are left wondering if we performed an unnecessary surgery due to a false positive margin assessment or if the cancer was missed again in the second surgery," said Irene Wapnir, MD, of Stanford University Medical Center in California, in a from Lumicell.

Support for FDA approval came from a of 357 patients undergoing image-guided lumpectomy for early-stage breast cancer. If post-lumpectomy imaging detected a pegulicianine signal, the surgeon performed a cavity-shave procedure.

The results showed that 27 (7.6%) of 357 patients had cancer in at least one cavity shave. Performance metrics included a sensitivity of 49.1% and specificity of 86.5%. Additionally, 43% of patients had at least one false-positive image and 8% had at least one false-negative result. According to Lumicell, use of pegulicianine with the DVS (LumiSystem) resulted in overall diagnostic accuracy of 84%.

"During lumpectomy surgery, surgeons still struggle to identify and remove all of the tumor during the first operation," said Barbara Smith, MD, PhD, of Mass General Brigham in Boston. "With the LumiSystem, we will now have a technology that is clinically proven to achieve a more complete cancer resection during lumpectomy that could help some patients avoid a second surgery."

According to Lumicell, the safety of the LumiSight system has been validated in more than 700 patients. In the pivotal trial, the most "clinically important" adverse reaction associated with LumiSight was hypersensitivity (1.4%), including anaphylaxis (0.6%). Labeling for the imaging agent includes a boxed warning about the risk of hypersensitivity reaction.

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