Nanosphere, Inc. (Nasdaq:NSPH),
a leader in the development and commercialization of advanced molecular diagnostics
systems, announced today it has received 510(k) clearance from the FDA for its
influenza A + B and respiratory syncytial virus (RSV) test and the Verigene
SP System, with complete sample-to-result automation.
"We are very pleased to receive clearance to provide our customers a better
performing and easier to use solution for diagnosing influenza and RSV viruses
in time for this flu season," said William Moffitt, Nanosphere's president
and chief executive officer. Mr. Moffitt added, "The attention drawn to
this flu season has highlighted the need for a respiratory virus test that offers
better sensitivity than the rapid strip tests and faster and easier testing
than cultures or currently available molecular tests. Our assay addresses these
needs and demonstrates the power and flexibility of the Verigene System. Nanosphere's
respiratory virus assay run on the Verigene SP platform provides clinicians
with the first sample-to-result system that combines the benefits of high sensitivity
and specificity with ease of use and rapid turn-around time."
The Verigene SP provides automated sample-to-result molecular diagnostics capabilities
in a multiplexed, random-access, modular system utilizing the same imaging technology
as the first generation Verigene, allowing for complementary or stand alone
integration into both molecular and microbiology laboratories.