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| The Verigene test cartridge, which is inserted into the benchtop reader for analysis--Courtesy of Nanosphere |
The FDA just cleared Nanosphere's ($NSPH) Verigene Respiratory Pathogens Flex Nucleic Acid Test for use on its benchtop analyzer.
The RP Test can identify up to 16 viral and bacterial targets, but labs pay for only the results of only the desired subset of targets, the company said. Additional targets can be selected if more information is needed from the patient sample. The targets include various types of influenza, RSV, parainfluenza and the bacteria Bordetella pertussis.
Results take two hours to process using the Verigene system. It consists of a benchtop reader and processor for nucleic acid extraction, purification, amplification (if necessary) and hybridization.
Single-use slides are inserted into the processor. The slides contains a microfluidic cassette consisting of hybridization reagents and a substrate holder for nucleic acid capture.
"The demand and need for respiratory pathogen testing varies by season, geography, epidemiology and patient demographics," said Paul Granato, professor of pathology at the State University of New York 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 clearance adds to Nanosphere's test menu, which also includes gram-positive and -negative bacteria, enteric pathogens, and the bacteria Clostridium difficile.
Following a $30 million IPO on the Nasdaq in 2013, the company last year raised $18.8 million by offer additional shares. It also transferred from the Nasdaq global market to the Nasdaq capital market because its stock price fell below the $1.00 threshold.
The company's shares now trade around $2.90 a pop.
- read the release