OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19
ROSWELL, Ga., and WESTBROOK, Maine, May 7, 2020—OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the 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.
“OPTI Medical Systems, IDEXX’s medical diagnostics business, can now support critical medical COVID-19 testing efforts, enabled by IDEXX’s extensive expertise in PCR test development and manufacturing. We have validated the OPTI SARS-CoV-2 RT-PCR test kit with existing laboratory customers and are advancing our initial distribution to select certified laboratories using common PCR platforms,” said Olivier te Boekhorst, Corporate Vice President and General Manager of OPTI Medical Systems, IDEXX Water, and IDEXX Livestock, Poultry and Dairy.
“The OPTI SARS-CoV-2 RT-PCR Test has an easy workflow with simple pipetting steps, making high throughput testing easy for medical technologists to perform. This minimizes errors and allows for effortless scalability,” said Dr. Hayley Webber, Technical Director, Molecular Diagnostics at NorDx Laboratories of Scarborough, Maine.
The OPTI SARS-CoV-2 RT-PCR test kit is based on real-time reverse transcription polymerase chain reaction (RT-PCR), which provides detection of the viral RNA in the sample. It is designed for the detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples. The OPTI SARS-CoV-2 RT-PCR test kit detects human RNase P as an internal sample control and endogenous nucleic acid to control for sample addition, extraction and amplification. The test kit provides results in approximately 2–3.5 hours and has been validated on commonly available qPCR instruments.
“This advancement is a true reflection of our talented global team coming together and leveraging innovation across our organization to bring a diagnostic solution to support COVID-19 testing during this unprecedented pandemic,” said Jay Mazelsky, President and Chief Executive Officer of IDEXX Laboratories.
The OPTI SARS-CoV-2 RT-PCR test kit was developed by utilizing the EUA process outlined by the FDA in March 2020. 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 to assist physicians in the diagnosis of COVID-19. The test kit is not FDA cleared or approved, CLIA waived, subject to an approved investigational device exemption or 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).
Bryan Briggs, General Manager, OPTI Medical Systems