FDAnews Device Daily Bulletin


March 20, 2006

The FDA has approved a new imaging system that can help detect a cervical cancer precursor, an indication of possible cancer development, by identifying sites on the cervix that may contain pre-cancerous cells.

The LUMA Cervical Imaging System, manufactured by MediSpectra , is intended to be used along with colposcopy, a high magnification evaluation of the cervix for women who have recently had an abnormal pap test.

The firm's study showed that the new device can detect additional cancer precursors missed by colposcopy. Of the 50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of cervical pre-cancer and LUMA caught an additional nine cases of cervical pre-cancer that colposcopy had missed.

The LUMA system shines a light on the cervix and analyzes how different areas of the cervix respond to this light. It assigns a score to tiny areas of the cervix and produces a color map that helps the doctor decide where to biopsy. The colors and patterns on the map help the doctor distinguish between healthy tissue, and potentially diseased tissue.

FDA's approval was based on data from the firm's clinical study of 193 women who underwent colposcopy, followed by LUMA. FDA's analysis showed that the device is safe and effective and that -- when used along with colposcopy -- the LUMA system will help detect additional cervical cancer precursors. ()a href="http://www.fdanews.com/ddl" target=_blank>