Nanosphere Receives FDA Clearance for First-of-Its-Kind Flexible Respiratory Pathogens Test

According to Nasdaq, Nanosphere has received FDA 510(k) clearance for its Verigene Respiratory Pathogens Flex Nucleic Acid Test.

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. The flexible panel concept addresses the varied respiratory testing needs of labs and clinicians with a single comprehensive, yet cost-effective solution.

“The demand and need for respiratory pathogen testing varies by season, geography, epidemiology and patient demographics,” said Paul Granato, Ph.D., 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.”