OPTI Medical Systems obtains FDA EUA for pooled testing and asymptomatic screening with the OPTI SARS-CoV-2 RT-PCR Test

The OPTI® SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for pooled testing and asymptomatic screening. This authorization supports the guidance from the U.S. Centers for Disease Control and Prevention (CDC) to expand COVID-19 testing to include people without symptoms to reduce the spread of the virus. The test is designed for the detection of SARS-CoV-2 RNA extracted from upper respiratory samples collected from any individual, including from individuals without symptoms or other reasons to suspect COVID-19 infection. In addition, it has been validated on nucleic acid extracts for the use of 5-specimen pool testing without compromising sensitivity or efficacy.

The OPTI SARS-CoV-2 RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. 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. Its low limit of detection enables pooling without reducing detection rate. Manufacturing of the assay and the sample preparation buffer 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.