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.
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).