LUMA™ Cervical Imaging System Approved for Detection of Pre-Cancerous Cells

LUMA™ Cervical Imaging System Approved for Detection of Pre-Cancerous Cervical Cells

The U.S. Food and Drug Administration (FDA) recently approved the use of the LUMA™ Cervical Imaging System to help identify areas of the cervix that may contain pre-cancerous or cancerous cells. The LUMA system is used in women immediately following a colposcopy to determine if further tissue should be removed for biopsy.

The cervix is a female reproductive organ that forms the lower portion of the uterus. Cervical cancer occurs when cervical cells grow out of control. When cells grow out of control, they spread and grow throughout the cervix and may invade and destroy neighboring organs. They may also break away and spread through the bloodstream and lymphatic system to other parts of the body.

Effective screening programs for cervical cancer have decreased the frequency of this disease. Screening can detect precancerous changes to the cervix, known as cervical intraepithelial neoplasia (CIN). Because the more severe types of CIN may progress to cervical cancer, removal of these lesions reduces the risk of cancer.

If areas of precancerous cells are found on the cervix, a colposcopy may be performed. During a colposcopy, a microscope and high-powered light are used to identify areas of the cervix that look abnormal. If abnormal areas are found during the exam, biopsies (samples of tissue) are removed and analyzed in laboratory. Physicians will then know what condition the patient has, including the presence of pre-cancerous or cancerous cells.

The LUMA Cervical Imaging System utilizes a special kind of light; different tissue types respond in distinct ways to this light. The LUMA system produces a color map according to how cervical tissues respond; physicians can then distinguish between healthy tissue and diseased tissue. The LUMA system is designed to be used immediately following a colposcopy so that physicians can determine if they have missed an area on the cervix that should be biopsied.

Women who are to undergo a colposcopy may wish to speak with their physician regarding their individual risks and benefits of the LUMA Cervical Imaging System.

Reference: United States Food and Drug Administration – Center for Devices and Radiological Health. New Device Approval LUMA™ Cervical Imaging System – P040028. Available at: http://www.fda.gov/cdrh/mda/docs/p040028.html. Accessed March 2006.

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