Nanogen, Inc., developer of advanced diagnostic products, announced today that it has delivered the second phase milestone requirements, including the point-of-care prototype device to detect influenza viruses rapidly in clinical samples, to the Center for Disease Control and Prevention (CDC) for their evaluation. Nanogen, together with business partner HX Diagnostics, had been awarded a contract from the CDC to fund an accelerated multiphase development plan for a rapid diagnostic test for pandemic flu. Delivery of the prototype device is an important milestone demonstrating the feasibility of meeting the CDC’s specifications for the rapid test. The company is continuing product development and initiating clinical trials with further funding of the project pending approval by the CDC.
“We’re very excited with the progress we have made on this project” stated Howard Birndorf, CEO of Nanogen. “Meeting the CDC requirements to develop a rapid but highly sensitive diagnostic test that would identify multiple influenza strains has been challenging. We’re proud of the innovative development work done by our team and pleased to bring our expertise in advanced diagnostic technologies and infectious diseases to bear on this important global healthcare problem.”
Each year 5%-20% of the U.S. population is affected by the influenza virus with approximately 36,000 deaths each year caused by the infection. Healthcare agencies, like the CDC, are concerned about the possibility of a deadly subtype, like avian flu, rapidly emerging and causing a pandemic. Tests like the one being developed by Nanogen under this contract will not only help healthcare providers to reliably diagnose the influenza virus but, also will be able to act as a sentinel for a potential outbreak of a pandemic H5 strain.