Luma Spectroscopy-Based Cervical Imaging System to be Reviewed by FDA
Apr 19, 2005 - 12:37:00 PM
Luma performs a 12-second scan, during which three optical measures native evoked fluorescence, diffuse reflectance backscatter and video imaging are employed to detect potential precancerous lesions on the cervix.
By FDA advisory committe, [RxPG] MediSpectra will present data from a 2,200-woman trial with its Luma spectroscopy-based cervical imaging system at FDAs Obstetrics & Gynecology Devices Panel meeting on May 17.
The clinical trial, started in 2002, studied women with abnormal Pap smears and compared the performance of Luma as an adjunct to colposcopy against colposcopy alone. Colposcopy, currently the gold standard, is a visual examination of the cervix using a large, electric microscope.
Luma performs a 12-second scan, during which three optical measures native evoked fluorescence, diffuse reflectance backscatter and video imaging are employed to detect potential precancerous lesions on the cervix.
The three measurements are refined and quantified further through multivariate analysis to provide tissue distinctions. Final results are displayed on a monitor as a false-color map that represents the cervix based on areas of disease probability.
MediSpectra claims a major advantage of the device is that it is not dependent on the expertise of the operator.
The Lexington, Mass. firms 604-patient pilot study showed that Luma detected 31% more high-grade precancerous lesions than colposcopy alone. The company has predicted the device eventually could replace colposcopy as the gold standard.
If approved, Luma would be the first spectroscopy-based imaging device for cervical cancer detection. In July, the firm was granted expedited PMA review by FDA.
However, MediSpectra is not alone in its efforts to market a cervical cancer detection device. SpectRx is working on a non-invasive detector and University of Texas at Austin is developing a spectroscopy device for precancerous cervical cells.
Australian firm Polartechnics offers a technology similar to Luma, but it is used as an adjunct to Pap smear and is only available in Australia and Italy.
The ob/gyn panel will also hear a presentation by the Center for Devices & Radiological Healths Office of Surveillance & Biometrics outlining their responsibility for the review of postmarket study design, FDA notes.
