ROSWELL, Georgia, and
WESTBROOK, Maine, June 5, 2020 /PRNewswire/ -- OPTI
Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc.
(NASDAQ: IDXX), today announced that it has received the CE mark
certification in the European Union for its OPTI® SARS-CoV-2 RT-PCR
laboratory test kit for the detection of SARS-CoV-2, the virus that
causes COVID-19. This announcement follows earlier validation of
the test by the Institut Pasteur of France as well as Emergency Use Authorization
(EUA) by the United States Food and Drug Administration (FDA).
Additionally, the FDA has granted EUA for the new OPTI DNA/RNA
Magnetic Bead Kit for nucleic acid extraction from respiratory
samples to be used with the OPTI SARS-CoV-2 RT-PCR test kit, which
enables OPTI Medical Systems to provide laboratories with a
complete OPTI Medical Systems-manufactured workflow solution for
COVID-19 testing.
"With the OPTI SARS-CoV-2 RT-PCR test kit, we benefit from an
optimized workflow and a test that has proven to deliver the
quality and accuracy that I would expect from a COVID-19 test.
Combined with the OPTI DNA/RNA Magnetic Bead Kit, we now have all
reagents needed for a complete solution for our COVID-19 PCR
testing needs," said Dr. Hayley
Webber, Technical Director, Molecular Diagnostics at NorDx
Laboratories of Scarborough,
Maine.
The OPTI SARS-CoV-2 RT-PCR test kit uses real-time reverse
transcription polymerase chain reaction (RT-PCR) technology and is
designed to provide results in approximately 2–3.5 hours.
"The CE mark certification is an important step in advancing our
efforts to support critical COVID-19 testing. We are committed to
helping our communities around the globe and will continue to work
with regulatory authorities and customers to expand the
availability of diagnostic testing," said Olivier te Boekhorst,
Corporate Vice President and General Manager of OPTI Medical
Systems, IDEXX Water, and IDEXX Livestock, Poultry and Dairy.
For details about the test kit and OPTI DNA/RNA Magnetic Bead
Kit, visit
optimedical.com/products-services/C19-test.html.
Product Disclosure
This CE mark certification represents OPTI Medical Systems'
assurance that its test complies with the European Union's In Vitro
Diagnostic Directive, which applies to products that are
manufactured in or designed to be sold in the European Economic
Area.
The OPTI SARS CoV-2 RT-PCR test kit has been authorized by the
United States Food and Drug Administration (FDA) under an Emergency
Use Authorization issued by the FDA on May
6, 2020. This test has not been FDA cleared or approved, and
the FDA has not determined that the test is safe or effective for
the detection of SARS-CoV-2. The test has been authorized only for
the detection of nucleic acid from SARS-CoV-2 and not for any other
viruses or pathogens. The test is only authorized for the duration
of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the U.S. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. Use in the United States
is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988, 42 U.S.C. § 263a (CLIA) to perform
high complexity tests. The test is not intended for home use.
About OPTI Medical Systems
OPTI Medical Systems, a subsidiary of IDEXX Laboratories, Inc.,
specializes in the design and manufacturing of point-of-care and
laboratory diagnostics for human medicine. OPTI Medical Systems
leverages advanced diagnostic technologies to develop reliable,
cost-effective products that combine accuracy with convenience,
ease of use and clinical flexibility.
About IDEXX Laboratories
IDEXX Laboratories, Inc. is a member of the S&P 500® Index
and is a leader in pet healthcare innovation, serving practicing
veterinarians around the world with a broad range of diagnostic and
information technology-based products and services. IDEXX products
enhance the ability of veterinarians to provide advanced medical
care, improve staff efficiency and build more economically
successful practices. IDEXX is also a worldwide leader in providing
diagnostic tests and information for livestock and poultry, tests
for the quality and safety of water and milk, and point-of-care and
laboratory diagnostics for human medicine. Headquartered in
Maine, IDEXX employs more than
9,000 people and offers products to customers in over 175
countries. For more information about IDEXX, visit idexx.com.
Note Regarding Forward-Looking Statements
This news release contains or may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
the use of words such as "expects," "may," "anticipates,"
"intends," "would," "will," "plans," "believes," "estimates,"
"should," "project," and similar words and expressions. These
forward-looking statements are intended to provide our current
expectation or forecasts of future events; are based on current
estimates, projections, beliefs, and assumptions; and are not
guarantees of future performance. Actual events or results may
differ materially from those described in the forward-looking
statements, as well as a number of assumptions concerning future
events. These statements are subject to risks, uncertainties,
assumptions and other important factors. Readers are cautioned not
to put undue reliance on such forward-looking statements because
actual results may vary materially from those expressed or implied.
The reports filed by IDEXX pursuant to United States securities laws contain
discussions of some of these risks and uncertainties. IDEXX assumes
no obligation to, and expressly disclaims any obligation to, update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise. Readers are advised to
review IDEXX's filings with the United States Securities and
Exchange Commission (which are available from the SEC's EDGAR
database at sec.gov and via IDEXX's website at idexx.com).
Product Information
OPTI Medical Systems
1-770-510-4444
covid19@optimedical.com
Investor Relations
investor-relations@idexx.com
Media Relations
media@idexx.com
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