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FDA Approves New Imaging System to Detect Cervical Pre-Cancer

March 19, 2006
The Food and Drug Administration 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, Inc. of Lexington, Mass., 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 9 cases of cervical pre-cancer that colposcopy had missed.

"Cervical cancer is one of the few highly preventable cancers. The early detection and removal of pre-cancerous cervical lesions reduces the risk of developing invasive cervical cancer," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health. "The approval of this imaging system gives health care providers an additional tool to help detect cervical cancer precursors and identify pre-disease that may have been missed by a colposcopy."

The LUMA Cervical Imaging System shines a light on the cervix and analyzes how different areas of the cervix respond to this light. The LUMA Systems 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.

A doctor will first perform a colposcopy and identify areas on the cervix to biopsy. The doctor will then evaluate the LUMA image to see whether or not there are additional areas of the cervix that should be biopsied. Only after both the colposcopy and LUMA procedures are completed does the doctor perform the biopsies.

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. Use of the LUMA device is not a substitute for a thorough colposcopic exam.

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