FDAnews Device Daily Bulletin

FDA APPROVES CERVICAL CANCER DETECTION TECHNOLOGY

March 30, 2006
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The FDA has approved the first optical detection system as an aid for clinicians when examining women with abnormal Pap tests.

Developed by Lexington, Mass.-based MediaSpectra, the LUMA cervical imaging system uses a light source to help physicians identify diseased areas on the cervix, including those likely to contain precancerous cells.

The device is used immediately after a colposcopy, an outpatient procedure for women with abnormal Pap smears, to determine where to extract additional tissue samples. In a colposcopy, a gynecologist uses a microscope and powerful light to examine the cervix and, if an abnormality is found, may remove a section of tissue for testing.

The LUMA device analyzes how different areas of the cervix respond to light, and assigns a score to various areas to produce a color map allowing doctors to distinguish where to conduct a biopsy. The colors and patterns on the map help the physician distinguish between healthy tissue, potentially diseased tissue and areas more difficult to interpret.

After the color-coded map is completed, the clinician evaluates the LUMA image to see whether additional areas of the cervix should be biopsied. After both the colposcopy and LUMA procedures are completed, the doctor performs the biopsies indicated from the results.

"Recent studies have shown that colposcopists can miss up to one-third of high-grade cervical cancer precursors, while use of the LUMA system demonstrated a significant increase in the detection of lesions that have a high risk of developing into cancer," said Ronald Alvarez, principal investigator in clinical trials conducted at the University of Alabama at Birmingham.

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