NEW YORK (360Dx) – Ceres Nanosciences said today it has received Breakthrough Device designation from the US Food and Drug Administration for its Lyme disease test.
The Breakthrough designation means FDA will work with Ceres to move the test from development to potential approval more quickly and at lower cost.
Ceres' Nanotrap Lyme Antigen Test System uses the company's Nanotrap technology to detect Lyme infections. The Nanotrap system consists of hydrogel nanoparticles functionalized with internal affinity baits to enrich target analytes for downstream analysis, thereby improving the sensitivity of the ultimate clinical detection method — for instance, ELISA or mass spectrometry. A urine-based test intended for use in point-of-care settings, the Lyme diagnostic is Ceres' lead product.
"We’re truly grateful to receive the FDA’s Breakthrough Device designation for the Nanotrap Lyme Antigen Test System," Ross Dunlap, Ceres' CEO said in a statement. "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."