OPTI Medical Systems COVID-19/Flu test obtains FDA Emergency Use Authorization
Roswell, GA, and Westbrook, ME, April 21, 2022—The US Food and Drug Administration has granted OPTI Medical Emergency Use Authorization for the OPTI® SARS-CoV-2/Influenza A/B RT-PCR Test. The test simultaneously detects and differentiates between SARS-CoV-2, influenza A and influenza B in a single reaction. It uses an internal sample control targeting human RNase P and minimizes impact of viral mutation with detection of two targets in the N region of SARS-CoV-2.
"This test will be an important tool for the influenza seasons for several years to come, helping healthcare professionals manage and control COVID-19", said Bryan Briggs, Director and General Manager of OPTI Medical Systems.
The OPTI SARS-CoV-2/Influenza A/B RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. In addition to the FDA EUA, it has also received CE marking. This test compliments the COVID-19 test portfolio of OPTI Medical, which also includes the OPTI® SARS-CoV-2 RT-PCR Test (FDA EUA, CE-IVD) and the OPTI® SARS-CoV-2 Total Antibody Test (CE-IVD). Manufacturing of the assay takes place at IDEXX's state-of-the-art PCR production facilities in Montpellier, France, along with other PCR products for COVID-19.
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.