Nanosphere, Inc. (NASDAQ:NSPH), a company enhancing the practice of medicine through targeted molecular diagnostics, today 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.

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 atLaboratory 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.” (Original Source)

Shares of Nanosphere closed last Friday at $2.70. NSPH has a 1-year high of $25.40 and a 1-year low of $2.06. The stock’s 50-day moving average is $2.68 and its 200-day moving average is $3.79.

On the ratings front, Nanosphere has been the subject of a number of recent research reports. In a report issued on August 12, Piper Jaffray analyst William Quirk maintained a Hold rating on NSPH, with a price target of $2.60, which represents a slight downside potential from current levels. Separately, on May 13, Canaccord Genuity’s Mark Massaro reiterated a Buy rating on the stock and has a price target of $5.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, William Quirk and Mark Massaro have a total average return of 3.6% and -9.4% respectively. Quirk has a success rate of 51.9% and is ranked #1514 out of 3747 analysts, while Massaro has a success rate of 30.9% and is ranked #3649.

Nanosphere Inc develops, manufactures and markets molecular diagnostics platform, the Verigene System, which enables sensitive genomic and protein testing on a single platform.