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

NORTHBROOK, Ill., Sept. 8, 2015 (GLOBE NEWSWIRE) -- 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 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."

About the Verigene® System

The Verigene System uses Nanosphere's core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The Verigene System rapidly and accurately detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus. Currently, the multiplexed Verigene assays target infections of the blood, respiratory tract and gastrointestinal tract. The information gathered from Verigene test results enables clinicians to make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy and reduced spread of antibiotic resistance.

About Nanosphere, Inc.

Nanosphere is enhancing medicine through targeted molecular diagnostics that result in earlier disease detection, optimal patient treatment and improved healthcare economics. The Company's versatile technology platform, the Verigene® System, enables clinicians to rapidly detect the most complex, costly and deadly infectious diseases through a low cost and simple-to-use multiplexed diagnostic test. The combination of this innovative technology and Nanosphere's customer-driven solutions keeps commitment to the patient at the forefront of its business. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.

Except for historical information, the matters discussed in this press release are "forward-looking statements" and are subject to risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: (i) Nanosphere's ability to develop commercially viable products; (ii) Nanosphere's ability to achieve profitability; (iii) Nanosphere's ability to produce and market its products; (iv) Nanosphere's ability to obtain regulatory approval of its products; (v) Nanosphere's ability to protect its intellectual property; (vi) competition and alternative technologies; and (vii) Nanosphere's ability to obtain additional financing to support its operations. Additional risks are discussed in the Company's current filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. The forward-looking statements are made as of the date of this press release, and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT: Investors: Michael Rice, LifeSci Advisors 646-597-6979 mrice@lifesciadvisors.com Media: Zachary Crowther, Director of Marketing 847-400-9074 zcrowther@nanosphere.us

Source:Nanosphere, Inc.