Ceres Nanosciences (Ceres) announced today that is has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its new point-of-care Nanotrap® Lyme Antigen Test System.
Under the Breakthrough Device program, formerly the Expedited Access Pathways program, the FDA works with a test developer to reduce the time and cost from development to approval.
The Ceres’ Nanotrap® Lyme Antigen Test System is a powerful diagnostic test that is intended to be available in point-of-care settings, like a physician’s office or a walk-in clinic. Requiring only a patient’s urine sample, it will deliver results to the physician and patient at the earliest stages of infection, when treatment is most successful.
“We’re truly grateful to receive the FDA’s Breakthrough Device designation for the Nanotrap® Lyme Antigen Test System,” said Ross Dunlap, Chief Executive Officer of Ceres Nanosciences. “This will accelerate our delivery to patients of a much needed test for Lyme disease, a devastating and increasingly common infectious disease that can cause irreparable harm if not detected and treated early on.”
To achieve Breakthrough Device designation, a device must demonstrate compelling potential to provide more effective diagnosis for life-threatening or irreversibly debilitating diseases. In addition, the device must meet at least one of the following criteria: represent breakthrough technologies; no approved or cleared alternatives exist; offer clinically meaningful advantages over existing approved or cleared alternatives; or the availability of which is in the best interest of patients.