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.
