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FDA Grants Emergency Use Authorization to Roche for SARS-CoV-2 Test

The world’s largest biotech company today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Roche cobas® SARS-CoV-2 Test.

Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples.

The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

Roche’s global install base for the cobas 6800 and 8800 Systems is 695 and 132 respectively.  The systems provide up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems.

About cobas SARS-CoV-2 Assay
The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria.The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The cobas SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 is only for use under the FDA’s Emergency Use Authorization.

About Emergency Use Authorization Status
The cobas SARS-CoV-2 Test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests.The test has been authorised only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. It is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorisation is terminated or revoked sooner.

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