OpGen Acuitas® MDRO Gene Test Approved by NY State Department of Health
July 12 2017 - 1:28PM
OpGen, Inc. (NASDAQ:OPGN) announced today that the
New York State Department of Health (NYSDOH) has approved the
Acuitas® MDRO Gene Test for use by physicians and healthcare
providers in the state. The approval of OpGen’s CLIA laboratory to
perform testing in New York State includes approval for the
complete OpGen MDRO testing workflow, including MDRO gene testing
on perianal swabs and clinical isolates. The NYSDOH regulates and
oversees clinical diagnostic laboratories that test specimens
from the state residents.
The Acuitas MDRO Gene Test is a CLIA lab-based test able to
provide information regarding the presence of ten MDRO resistance
genes from one patient specimen. The ten drug-resistant genes
identified by our Acuitas MDRO Gene Test are associated with CRE,
ESBL and VRE organisms, and are gastrointestinal organisms
frequently associated with antibiotic-resistant infections. The
test results can be used by healthcare providers to identify
patients colonized with organisms expressing the drug-resistant
genes or who are actively infected.
Evan Jones, Chairman & CEO, commented, “We are pleased to
receive approval by the NYSDOH to provide our services to
healthcare institutions in NY State. The NY State Clinical Lab
Evaluation Program conducts rigorous evaluations of new clinical
lab tests, and we are honored to receive this important approval
for our technology. By making our testing available to NY State
healthcare providers, we hope to help combat the rising Superbug
Multi-drug Resistant pathogen issue.”
About MDROs
Multi-drug resistant organisms (MDROs) are common bacteria that
have developed resistance to multiple classes of antibiotics. They
are a leading cause of healthcare-acquired infections and are
associated with an increase in morbidity and mortality. Each year,
more than two million Americans acquire infections that are
resistant to antibiotics. Asymptomatic carriers are at a higher
risk of an MDRO infection and become reservoirs for transmission to
other patients in health care systems if not accurately identified
early. Since there are many types of antibiotic resistant
organisms, and the way they cause disease is influenced by their
genetics, knowing the exact genetic profile of these organisms is a
key step to preventing their ability to infect.
About OpGenOpGen, Inc. is harnessing
the power of informatics and genomic analysis to provide complete
solutions for patient, hospital and network-wide infection
prevention and treatment. Learn more at www.opgen.com and
follow OpGen on Twitter and LinkedIn.
OpGen, Acuitas, Acuitas Lighthouse and QuickFISH are
registered trademarks of OpGen, Inc.
Forward-Looking StatementsThis press release
includes statements relating to the Company's products and
services. These statements and other statements regarding OpGen’s
future plans and goals constitute "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, and are
intended to qualify for the safe harbor from liability established
by the Private Securities Litigation Reform Act of 1995. Such
statements are subject to risks and uncertainties that are often
difficult to predict, are beyond our control, and which may cause
results to differ materially from expectations. Factors that could
cause our results to differ materially from those described
include, but are not limited to, our ability to successfully,
timely and cost-effectively develop, seek and obtain regulatory
clearance for and commercialize our product and services offerings,
the rate of adoption of our products and services by hospitals and
other healthcare providers, the success of our commercialization
efforts, the effect on our business of existing and new regulatory
requirements, and other economic and competitive factors. For a
discussion of the most significant risks and uncertainties
associated with OpGen's business, please review our filings with
the Securities and Exchange Commission (SEC). You are cautioned not
to place undue reliance on these forward-looking statements, which
are based on our expectations as of the date of this press release
and speak only as of the date of this press release. We undertake
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
OpGen Contact:Michael FarmerDirector,
Marketing240-813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Investor Contact:LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.comorBruce
Voss310-691-7100bvoss@lhai.com
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