SpectraScience (San Diego) reported that the FDA has given approval to the company to manufacture its WavStat Optical Biopsy System in its Sorrento Valley facility.
CEO Jim Hitchinsaid the approval is the result of the company's submission of a PMA supplement to its existing approved PMA.
The WavStat Optical Biopsy System is able to distinguish between normal, pre-cancerous, or cancerous tissue optically as compared to the current technique of physically removing suspected tissue and waiting for a pathology report.
The system is currently approved by the FDA for use in detecting cancer in the colon. A new application for detecting pre-cancers in the throat is being tested in a clinical trial.