The US Food and Drug Administration (FDA) has accepted premarket approval for Lumicell’s breast cancer detection assistance device.

The Lumicell Direct Visualisation System (DVS), which was granted fast track designation by the FDA in November 2020, is designed to detect residual cancerous tissue within the lumpectomy cavity following breast-conserving surgery. Along with the PMA application, the FDA has also granted priority review for New Drug Application (NDA) for the Lumisight optical imaging agent (pegulicianine) that will be used with the device for fluorescence imaging. Both products are currently limited to investigational use only.

A hand-held imaging probe, supported by cancer detection software, can be inserted inside the breast cavity to identify any cancer cells that remain. Because surgeons examine margins of excised tissue to ascertain whether all cancer cells have been removed, a section of lumpectomies only have margin results a few days after surgery. Lumicell say that, with its system, surgeons will be able to detect residual cancer during the initial lumpectomy.

Data from 700 breast cancer patients across five clinical studies were used to support the application. In a pivotal trial (NCT03686215), Lumicell DVS identified cancer remaining after the standard of care lumpectomy procedure in approximately 8% of patients. In addition, 14.5% of patients who initially seemed to possess residual cancer were found to have cancer-free margins, potentially avoiding a second surgery.

“The FDA acceptances of both the NDA and PMA submissions for our Lumisight Optical Imaging Agent and Lumicell Direct Visualization System bring us one step closer to advancing care for women with breast cancer,” said Kevin Hershberger, president, and chief executive officer of Lumicell.

“Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment. We look forward to the FDA’s review of our applications, and the potential to offer surgeons the first visualisation system to enable a more complete cancer resection during the initial lumpectomy.”

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