OPTI Medical Systems Receives EUA for OPTI SARS-CoV-2 RNA PCR Test Kit for COVID-19

OPTI Medical Systems announced 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.

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