OPTI Medical Systems, Inc. news

The OPTI SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI Rapid Lysis Buffer. The OPTI Rapid Lysis Buffer protocol eliminates the need for magnetic bead or spin column extraction and prepares the samples for PCR testing using a simple heating protocol. The OPTI Rapid Lysis Buffer has shown a diagnostic sensitivity and specificity of 100 % when compared to magnetic bead extraction.

The PCR testing workflow for SARS-CoV-2

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that it has received the CE mark certification in the European Union for its 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 as well as Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA).

Additional

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that 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

OPTI Medical is pleased to announce the launch of our E-Lyte CCA cassette for use on the OPTI CCA-TS and TS2 Blood Gas and Electrolyte Analyzers. With measured pH, Na⁺, K⁺, Ca⁺⁺, Cl^- and calculated tCO₂ and HCO₃^-, the E-Lyte CCA test configuration is designed to assist in the detection of renal fail