SpectraScience, Inc., a medical device company, announced today that the U.S. Food and Drug Administration has given approval to manufacture its LUMA(R) Cervical Cancer Imaging System in its San Diego facility. The LUMA Cervical Imaging System was developed to significantly improve the detection of high-grade pre-cancerous cervical abnormalities that have the potential to become invasive cancer.
Almost a thousand women die every day worldwide from cervical cancer. It is estimated that pre-cancerous cervical disease goes undiagnosed in about 200,000 American women each year. The LUMA System provides a safe, non-invasive and effective method, that when used as an adjunct to colposcopy, has been demonstrated to uncover at least 26% more high-grade precancerous disease than colposcopy alone.
SpectraScience CEO Jim Hitchin commented, "This approval is key for us to begin manufacturing the LUMA Systems here in our San Diego facility. This milestone provides FDA validation of our manufacturing expertise and removes production capacity constraints related to the marketing of the LUMA System as an important tool in the early detection of cervical cancer."
SpectraScience has filed for 60 patents worldwide on its WavSTAT(R) Optical Biopsy and LUMA Cervical Cancer Imaging Systems that are used to diagnose tissue to determine within seconds if it is normal, pre-cancerous, or cancerous. The WavSTAT and LUMA 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 ("Barrett's esophagus") is being tested.