Verigene(R) Enteric Pathogens Test Receives FDA Clearance
NORTHBROOK, Ill., June 24, 2014 (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 the bacterial portion of its
Verigene® Enteric Pathogens Nucleic Acid Test (EP). Clinical studies for the
full panel, including two additional viral targets, have been completed and
the Company expects clearance of the full EP panel.
Nanosphere management will host a live conference call and webcast on
Wednesday, June 25, 2014 at 8:30am Eastern/5:30am Pacific to discuss the
Company's regulatory strategy for Verigene EP.
Verigene EP is an automated in vitro diagnostic test that simultaneously
identifies a broad panel of common community-acquired pathogenic enteric
bacteria and genetic virulence markers directly from a stool sample, two to
three days faster than the time- and labor-intensive conventional
Diarrhea caused by bacterial and viral infection represents a significant
healthcare burden in the U.S. While most cases of community-acquired diarrhea
are self-resolving and not life-threatening, gastrointestinal infections in
the U.S. are associated with 3.7 million emergency department visits, 1.3
million inpatient hospitalizations and more than $6 billion in healthcare
costs per year.^i
Since symptoms alone are insufficient to make treatment decisions, rapid
identification of the bacterial or viral cause of diarrhea is critical for
optimal patient management, limiting the prescription of inappropriate or
The Verigene EP Test joins Nanosphere's currently marketed Verigene
Clostridium difficile Nucleic Acid Test (CDF), which identifies toxigenic C.
difficile and differentiates the 027 hypervirulent strain for epidemiological
purposes. C difficile infections are most commonly associated with use of
antibiotics and are responsible for 250,000 hospitalizations and at least
14,000 deaths per year in the U.S., and were recently highlighted by the
Centers for Disease Control and Prevention as a healthcare-acquired infection
posing an urgent health threat in the U.S.^ii
The Company will submit additional data to the FDA for the two viral targets
to be included on Verigene EP imminently.
"FDA clearance of Verigene EP further strengthens our portfolio of multiplexed
molecular gastrointestinal tests and expands our ability to deliver clinical,
economic and workflow benefits to those hospitals and laboratories which have
adopted our Verigene System," said Michael McGarrity, Nanosphere's president
and chief executive officer. "Our menu offerings addressing community and
healthcare-acquired infections enable our customers to run the most
appropriate test for each patient based on their respective clinical
presentation and health history."
Nanosphere's menu of infectious disease tests are performed using the
automated, sample-to-result Verigene System. Its ease of use and on-demand
workflow makes Verigene a viable diagnostic platform for use in both
hospital-based and reference laboratories across the country, regardless of
Conference Call & Webcast
Wednesday, June 25, 2014 @ 8:30am Eastern Time/5:30am Pacific Time
Replays – Available through July 9, 2014
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.
^i Healthcare Cost and Utilization Project. Statistical Brief #150: Infectious
Enteritis and Foodborne Illness in the United States, 2010.
^ii Centers for Disease Control and Prevention, U.S. Department of Health and
Human Services. Antibiotic Resistance Threats in the United States, 2013.
Accessed June 18, 2014.
Roger Moody, Chief Financial Officer
Michael Rice, LifeSci Advisors
Lindsey Saxon, Director of Communications
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