LEXINGTON, Mass., March 16 /PRNewswire/ -- MediSpectra, Inc. announced today that its PMA application for the LUMA(TM) Cervical Imaging System has received approval from the U.S. Food and Drug Administration (FDA). The LUMA system is the first optical imaging device approved as an aid to clinicians examining women with abnormal Pap tests. The device, when used as an adjunct to colposcopy, is expected to reduce the number of high-grade cervical cancer precursors (lesions that are at high risk of developing cancer) that are missed when women are evaluated for abnormal Pap tests.
The LUMA system is a non-contact optical imaging device that when used as an adjunct to colposcopy detects significantly more high-grade cervical cancer precursors than the current standard of care, colposcopy alone. The LUMA system was evaluated in clinical trials involving more than 3,500 women by over 50 colposcopists at 15 clinical practice centers throughout the United States.
Ronald D. Alvarez, M.D., a principal investigator in the clinical trials at the University of Alabama at Birmingham, stated, “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.” Thomas C. Wright, M.D., consulting Medical Director for MediSpectra, commented that “this is a significant step forward for early detection and treatment of cervical cancer and its precursors, particularly those found in women with low-grade abnormal Pap tests who are often the most difficult to evaluate.”
The LUMA system scans tissue with a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy, and video imaging. A complete scan takes 12 seconds, with results available to the clinician during the examination. The LUMA system is the only FDA-approved optical device designed to evaluate the cervix as an aid in the early detection of high-grade cervical cancer and its precursors.
Robert B. Anacone, Chairman of MediSpectra, commented that “approval of the LUMA system is a major milestone for MediSpectra that marks the start of our commercialization phase.” “Moreover,” continued Mr. Anacone, “we are fully committed to further clinical studies of the LUMA system and we expect that the launch of this product will be the first in a series of new technologies that will truly help to save lives and significantly improve the practice of women’s healthcare.”
About MediSpectra
MediSpectra is a privately held medical device company dedicated to the development of superior quality optical detection products that improve early detection of cancer. MediSpectra’s first product, the LUMA(TM) Cervical Imaging System, addresses the critical need of improving the practice of colposcopy for cervical cancer detection. Applications to other cancers are expected in later products.
MediSpectra is headquartered at 45 Hartwell Avenue, Lexington, MA 02421 (www.medispectra.com, 781-372-2300).
MediSpectra, Inc.
CONTACT: Theresa Wingrove of MediSpectra, +1-781-775-1170 ortwingrove@medispectra.com; or Tracy Morris, +1-650-473-1272 ortracy@morrismarcom.com, for MediSpectra
Web site: http://www.medispectra.com/
