The US Food and Drug Administration (FDA) has issued an approvable letter for Dune Medical Devices’ premarket approval application (PMA) for its MarginProbe breast cancer detection system.
The letter indicates that the system’s PMA will be approved, subject to final agreement with the FDA on the post-approval study design.
Early detected breast cancer patients, in general, undergo a lumpectomy procedure as their initial treatment versus mastectomy, which involves the removal of the whole breast.
Lumpectomy, in combination with radiation therapy, is also considered as effective in combating breast cancer as mastectomy, in which no cancer cells are present on the rim or edge of the removed tissue.
Research studies show that there is no significant difference in overall survival between the two procedures, however, if there is cancer at the edge, or a ‘positive margin’, the risk of recurrence increases, thus resulting in repeated surgeries, according to the company.
To overcome the repeated surgeries, the MarginProbe system uses electromagnetic waves to detect microscopically positive margins and characterise human tissue in real-time, to provide intraoperative information on the malignancy of the surface of the ex-vivo lumpectomy specimen.
Intended for use on tissue within 20 minutes of excision, the system is indicated for intraoperative use in conjunction with intraoperative imaging and palpation.
Dune Medical Devices CEO Daniel Levangie said the company will work diligently over the coming weeks to develop the final design of the post approval study.
"Having completed our discussions with FDA related to product labeling, the post-approval study is the only remaining issue to be resolved prior to final approval," Levangie said.