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.