Ceres Nanosciences’ Point-of-Care Nanotrap® Lyme Antigen Test System Granted Breakthrough Device Designation by U.S. Food and Drug Administration
Press Release: Ceres Nanosciences, Inc., Manassas, Virginia
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.
About Ceres Nanosciences, Inc.
Ceres Nanosciences is a privately held company, located in Prince William County, Virginia, focused on the development of research and diagnostic products using its unique and proprietary Nanotrap® particle technology. The Nanotrap® particle technology provides powerful biomarker capture and biofluid sample processing capabilities for a wide array of diagnostic applications and sample handling needs. The Nanotrap® particle technology was invented at George Mason University and developed under funding from the National Institutes of Health (NIH). With support from the NIH, the Defense Advanced Research Projects Agency (DARPA), the Bill and Melinda Gates Foundation, and the Commonwealth of Virginia, Ceres is focused on incorporating this technology into a range of innovative diagnostic products. Learn more at www.ceresnano.com http://www.ceresnano.com
Ross M. Dunlap
Ceres Nanosciences, Inc
1.800.615.0418 ext. 202
Direct quote from Ceres: http://www.ceresnano.com/nanotrap-lyme-test
The Nanotrap® Lyme Antigen (LA) Test is a novel, high sensitivity, DIRECT test for Lyme that will provide valuable information to assist a physician in diagnosing and treating Lyme disease at most stages of infection.
So this is not the end all. People are going to slip through cracks here as well. Please keep this in mind.
While using urine samples to directly detect Bb, (other tests use indirect testing by testing for antibodies), it relies on Bb being in the urine. We all know Bb is a stealth organism that goes where it pleases – Often where it can’t be found.
Samuel Shor, MD, FACP: We’re involved in the study of 2 tests that are very promising. One is called the Nanotrap, which looks at a highly specific protein called OspA that is found across multiple strains of Borrelia. And what this technology does is super concentrate, in a urine sample, the presence of this protein and then further tests it, and, it’s 1000-fold more sensitive than the standard Western Blot. In our 2015 paper that was published in the Journal of Translational Medicine, in the preliminary erythema-migrans patients—who are very often negative in the ELISA test because they haven’t had the time to respond immunologically—24 out of 24 were positive with the Nanotrap test.
So it looks better but it’s not perfect…..