Nanosphere announced this week that is has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) on the automated, sample-to-result Verigene System.
The first test of its kind, RP Flex features Nanosphere’s novel Flex™ software, which allows the 16 viral and bacterial targets identified by RP Flex to be reported as a full multiplex panel or in various user-defined subsets. Labs pay for only the targets ordered for each patient sample.
Additional target results not originally reported can be revealed instantly without running an additional test if the clinician requests additional testing for a given patient. With this built-in flexibility, RP Flex can provide labs with a solution for flu only testing, flu and RSV testing, broad respiratory viral testing, and pertussis-only testing all from a single cartridge.
“The demand and need for respiratory pathogen testing varies by season, geography, epidemiology, and patient demographics,” said Paul Granato, PhD, Director of Microbiology at Laboratory Alliance of Central New York and Professor Emeritus of Pathology at SUNY Upstate Medical University. “RP Flex is the first respiratory test that provides labs with the flexibility to choose and pay for only the microbial targets applicable to a given patient, which in turn allows them to practice better test stewardship and reduce healthcare costs.”
The choice is yours with RP Flex.
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