Medical Device Network

FDA panel gives go-ahead to Lumicell’s breast cancer detection tool

The agency will now decide on Lumicell DVS’ PMA and the Lumisight NDA following the advisory committee’s positive decision.

A US Food and Drug Administration (FDA) panel has issued a positive recommendation for Lumicell’s surgical imaging tool for breast cancer detection.

The FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 16-2 in favour of the benefit-risk profile of Lumisight (pegulicianine) – an optical imaging agent used in combo with the company’s direct visualisation system (DVS). Together, the products detect residual cancer in real time during lumpectomy surgery.

Though FDA panel recommendations are non-binding, they form a good indication as to which direction the agency will sway when deciding on market approval.

Lumicell’s premarket application (PMA) gained fast track designation in 2020 while the imaging agent’s new drug application (NDA) is under priority review.

The FDA has not set a date for approval verdicts, with decisions expected on the PMA and NDA expected in the “near future”, according to Lumicell.

The MIDAC’s positive decision was based on efficacy data from more than 350 patients in a pivotal study (NCT03686215) and safety data from over 700 patients across multiple clinical trials.

Lumicell’s tech includes a hand-held imaging probe, supported by cancer detection software, that can be inserted inside the breast cavity to identify any cancer cells that remain during lumpectomy – otherwise known as breast-conserving surgery.

Surgeons examine margins of excised tissue to ascertain whether all cancer cells have been removed, though a proportion of lumpectomies only have margin results a few days after surgery. Lumicell says that, with its system, surgeons will be able to detect residual cancer during the initial lumpectomy in real time.

Lumicell’s device gained fast track designation in 2020, whilst the imaging agent’s new drug application is under priority review.

The Massachusetts-based company was founded in 2008 after founding CEO David Lee’s wife died of breast cancer. Fellow co-founder Moungi Bawendi won the Nobel Prize in Chemistry last year for work on quantum dots.

Lumicell’s CEO Jorge Ferrer said: “We look forward to working with the FDA as it completes its review of Lumisight’s NDA and Lumicell DVS’ PMA application.”

The global diagnostic imaging market was estimated to be worth nearly $32bn in 2023 and is predicted to grow to over $45bn by 2030, according to a report by GlobalData.

Also in the breast cancer imaging space is Clarix Imaging, which raised $10m to advance its 3D imaging platform last October.