OPTI Medical Systems COVID-19/Flu test obtains FDA Emergency Use Authorization

Roswell, Georgia - 27 April 2022 - The US Food and Drug Administration granted OPTI Medical Emergency Use Authorization for the OPTI® SARS-CoV-2/Influenza A/B RT-PCR Test on April 21st. 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: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.