IDEXX-Made OPTI SARS-CoV-2 RNA PCR Test Kit Secures FDA Emergency Use Authorization

IDEXX Laboratories, Inc.’s (Westbrook, ME, USA) subsidiary, OPTI Medical Systems, Inc. (Roswell, GA, USA), has been granted Emergency Use Authorization (EUA) by the US FDA for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2.

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 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.

"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.