In July, Ceres Nanosciences (Ceres) announced it received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its new point-of-care Nanotrap Lyme Antigen Test System. This diagnostic test requires only a patient’s urine sample to deliver results to the physician and patient at the earliest stages of infection, when treatment is most successful.
Under the Breakthrough Device program, the FDA works with a test developer to reduce the time and cost from development to approval.
Ross Dunlap, Chief Executive Officer of Ceres Nanosciences said the designation is important for several reasons, first because it means the test can more quickly be moved out of the clinical lab at George Mason University and into the general market where it can be shared by practitioners, other labs and distributors.
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