Nanosphere Receives FDA Clearance for Respiratory Pathogens 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."

Verigene RP Flex joins Nanosphere's growing menu of infectious disease tests, including:

• Verigene Gram-Positive and Gram-Negative Blood Culture Tests, which identify bacteria and related antibiotic resistance markers associated with bloodstream infections and sepsis (FDA-cleared; CE-Mark)

• Verigene Enteric Pathogens Test, which identifies bacteria, viruses, and toxins that cause acute gastroenteritis (FDA-cleared; CE-Mark)

• Verigene Clostridium difficile Test, which identifies C. difficile – the cause of deadly hospital-acquired diarrhea (FDA-cleared; CE-Mark)

"Verigene RP Flex addresses a previously unmet healthcare need for our laboratory customers by bridging the gap between one-size-fits-all syndromic panels and targeted single-analyte tests," said Michael McGarrity, Nanosphere's president and chief executive officer. "RP Flex puts testing decisions back in the hands of healthcare professionals and allows for optimal clinical and economic utility."