News | March 03, 2009

SpectraScience Receives FDA Clearance for Manufacturing Facility

March 3, 2009 - SpectraScience Inc. said today that the FDA has given approval to manufacture its LUMA 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 aims to provide a safe, noninvasive and effective method, that when used as an adjunct to colposcopy, has been demonstrated to uncover at least 26 percent 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 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.

For more information: www.spectrascience.com

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