LUMA CERVICAL IMAGING SYSTEM
SPECTRA SCIENCEThe LUMA Cervical Imaging System is a non-contact optical analysis device that assists colposcopists in identifying high-grade cervical lesions (CIN 2,3+) by scanning the cervix with laser-induced fluorescence and reflectance spectroscopy. It provides computer-analyzed images with color-coded overlays to guide biopsy site selection, helping clinicians detect cervical abnormalities more accurately.
Intended Use
The LUMA Cervical Imaging System is indicated for use as an adjunct to colposcopy for the identification of high-grade disease (CIN 2,3+) in women referred to colposcopy with abnormal Pap test results.
Technology
The system consists of a console with laser (ultraviolet laser, broadband flashlamp), spectrometer, video camera, and illumination probe. It performs a 12-second scan of the cervix using laser-induced fluorescence and diffuse reflectance spectroscopy at multiple sites. The software algorithm integrates spectral and imaging data to generate a color-coded classification overlay to indicate tissue likelihood of high-grade CIN.
Performance
Clinical studies involving over 3500 women showed the system detects additional cases of CIN 2,3+ missed by colposcopy with an approximate 22% relative gain in detection at the cost of about one extra biopsy per patient. No serious adverse events related to the device occurred. Bench and safety testing demonstrated compliance with electrical, mechanical, and optical safety standards.
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