Massachusetts-based Lumicell has received US Food and Drug Administration (FDA) approval for its breast cancer visualisation system dubbed LumiSystem.

LumiSystem system combines LUMISIGHT (pegulicianine) optical imaging agent and Lumicell direct visualisation system (DVS), which is a fluorescence imaging device.

Separately, the FDA approved the company’s new drug application (NDA) for LUMISIGHT. On the other hand, Lumicell DVS secured premarket approval (PMA).

The drug-device breast cancer detection combination system is designed to illuminate cancerous tissue. It performs real-time breast cavity scanning following a lumpectomy to identify and remove any residual cancer that might have gone undetected.

According to Lumicell, LumiSystem has an 84% diagnostic accuracy rate and potentially saves some patients from needing repeat procedures.

The LumiSystem combo is recommended for fluorescence imaging in adults with breast cancer.

It is indicated as a supplement during intraoperative detection of malignant tissue after the primary specimen is removed during lumpectomy surgery.

Previously, LUMISIGHT and Lumicell DVS secured FDA fast track and breakthrough device designations, respectively.

Lumicell president and chief operating officer Howard Hechler said: “We are immensely proud of the dual approval of LUMISIGHT and Lumicell DVS – we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes.

“With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.”

LumiSystem’s safety was determined from the results of over 700 breast cancer patients at some of the academic and community cancer centres across the US.

LUMISIGHT is also being assessed for further development for a wide variety of solid tumour indications.

Lumicell chief scientific officer Jorge Ferrer said: “We want to thank our clinical investigators and the hundreds of women who participated in our breast programme for LUMISIGHT and Lumicell DVS.

“Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the US shortly.”