FDA clears flexible respiratory pathogen test
Nanosphere has obtained Meals and Drug Administration 510(k) clearance for its Verigene Respiratory Pathogens Flex Nucleic Acid Check on the automated sample-to-result Verigene System.
RP Flex options Nanosphere’s Flex software program, which permits the 16 viral and bacterial targets recognized by RP Flex to be reported as a full multiplex panel or in varied user-defined subsets. Labs pay for less than the targets ordered for every affected person pattern. The versatile panel idea addresses the numerous respiratory testing wants of labs and clinicians with a single complete, but cost-effective answer.
“RP Flex is the primary respiratory take a look at that gives labs with the flexibleness to decide on and pay for under the microbial targets relevant to a given affected person, which in flip permits them to follow higher check stewardship and scale back well being care prices,” Paul Granato, PhD, mentioned in a Nanosphere assertion. Dr. Granato directs microbiology at Laboratory Alliance of Central New York.
The Verigene System makes use of Nanosphere’s nanoparticle chemistry to supply extremely delicate, extremely particular molecular diagnostic outcomes via low-cost multiplexing. The Verigene System quickly and precisely detects infectious pathogens and drug-resistance markers by concentrating on conserved genetic areas of a bacterium or virus.