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Medical device maker SpectraScience, Inc. said that the U.S. Food and Drug Administration has given the company approval to manufacture its Luma Cervical Cancer Imaging System in its San Diego facility.

 

The Luma Cervical Imaging System was developed to improve the detection of high-grade pre-cancerous cervical abnormalities that have the potential to become invasive cancer.

According to SpectraScience, the Luma System is meant to be used in conjunction with colposcopy, a traditional method of detecting the disease, and according to the company "has been demonstrated to uncover at least 26% more high-grade precancerous disease than colposcopy alone."

SpectraScience has filed for 60 patents worldwide on its WavStat Optical Biopsy and Luma Cervical Cancer Imaging Systems that are meant to diagnose tissue to determine within seconds if it is normal, pre-cancerous, or cancerous. The systems are currently approved by the FDA for detecting pre-cancer and cancer in the colon and cervix, and an evaluation for detection of pre-cancers in the throat is being tested.

San Diego-based SpectraScience is a medical device company that designs, develops, manufactures and markets spectrophotometry systems designed to determine whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body.

Source: SpectraScience, Inc.