SANTA CLARA, Calif., Sept. 8 -- The US Food and Drug Administration has approved Applied Imaging Corp.'s MDS system to help pathologists locate micrometastatic cells in bone marrow specimens that are associated with the spread of a rare form of cancer.
This rapid FDA clearance of the first clinical application for the MDS represents the achievement of a significant milestone for the company, said Jack Goldstein, chairman and CEO of Applied Imaging. Our clinical data showed that pathologists using the MDS detected 46 percent more patients with metastatic cells than they detected by unaided microscopic examination. This substantial improvement will allow us to market the MDS system to thousands of cancer centers worldwide, presenting us with a dramatically expanded opportunity for the company's products.