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.
But the designation also means Ceres has access to the FDA’s direct feedback. “Getting more attention and focus means it’s easier to get things right during the clinical study,” he said. Dunlap said they hope to submit the clinical study next year and have it on the market by the end of 2019.
Dunlap said the project has received funding at the county, state and federal levels. At the county level, Dunlap said they received funds for their initial move to a larger space, which indirectly supported the current research. Ceres has also received state funding earmarked for research on tick-borne diseases, such as lyme. Federal funding has come from large entities such as the DOD and NIH.
Behind the device is Nanotrapparticle technology, a biomarker capture and biofluid sample tech used for a wide array of diagnostic applications and sample handling needs.
Dunlap said what is especially important to note is that Ceres is not a med tech company. “We’re and innovative tech company,” he said. “But the Nanotrap technology is being used in this way, being used in as many innovative ways as possible.”
Cere’s initial press release said that 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.”
