HX Diagnostics, Inc. announced today that it has expanded its license and development agreement with Nanogen, Inc. to include the development of additional rapid, point-of-care diagnostics for respiratory infectious diseases. As part of the three-year agreement, the companies will employ the same underlying technology used in their previously announced joint project, a diagnostic for the differential diagnosis of seasonal and pandemic influenza.
The companies are currently in the final stages of development on a highly sensitive diagnostic assay that can simultaneously detect multiple strains and subtypes of influenza, including avian influenza, with one simple and rapid test. The fluID Rapid Influenza Test is an easy-to-use, low cost device utilizing high affinity monoclonal antibodies and proprietary lateral flow technology from Nanogen. The technology is capable of detecting and differentiating multiple analytes in the sample. In pre-clinical trials, the assay demonstrated greater than 2 logs improvement in sensitivity over currently available assays.
The same proprietary lateral flow technology and device design will be used in the newly announced development programs. Once development is complete, HX Diagnostics will be granted exclusive commercial license to manufacture and market the resulting products upon regulatory approval.
“The expanded agreement with Nanogen gives us the opportunity to open up our potential market by providing full panels of diagnostics for respiratory illnesses,” said Wendy Benson, president and chief executive officer of HX Diagnostics. “The rapid, accurate diagnosis of these infectious diseases will enable quicker treatment and recovery times for patients.”
The development of the fluID test is supported in part by a 2006 grant from the U.S. Centers for Disease Control and Prevention as part of the U.S. government’s efforts to strengthen its readiness for a potential influenza pandemic.
”Our R&D efforts on the CDC/HX avian influenza project have resulted in a next generation rapid diagnostic technology with breakthrough improvements in sensitivity and precision,” said David Ludvigson, Nanogen’s president and chief operating officer. “Expanding our relationship with HX Diagnostics to include additional respiratory disease diagnostics is a good way for Nanogen to leverage the technology and fulfill our mission of enabling better patient care by bringing to market easier and faster diagnostics.”