Nanosphere Gets FDA OK For First-of-Its-Kind Flexible Respiratory Pathogens Test

(RTTNews) - Molecular diagnostics company Nanosphere, Inc. (NSPH) announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) on the automated sample-to-result Verigene System.

Verigene RP Flex addresses a previously unmet healthcare need for its laboratory customers by bridging the gap between one-size-fits-all syndromic panels and targeted single-analyte tests.

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 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.

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