- First commercial test for SARS-CoV-2 to meet urgent medical needs
- Testing on widely available, high-volume Cobas 6800/8800 will significantly increase available testing capacity
- Roche expedites test development for supporting urgent need for patient testing during pandemic outbreak for avoiding a further spread of the virus at an early stage of infection
March 13, 2020- Roche announced that FDA has issued an Emergency Use Authorization (EUA) for its Cobas SARS-CoV-2 Test. This test is intended to detect SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. The test can be run by the hospitals and reference laboratories on fully automated Cobas 6800 and Cobas 8800 Systems that are extensively available in the US and across the globe.
With the cobas 6800/8800 Systems, the test results are provided in three and half hours. In addition, it offers improved operating efficiency as well as the fastest time-to-results with the highest throughput providing up to 96 results in about 3 hours a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in 8 hours.
About Emergency Use Authorization Status
Cobas SARS-CoV-2 Test has not been approved or cleared by the FDA. The FDA has authorized the system under EUA to be used by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a. The system tends to perform performing moderate and high complexity tests. The regulatory body has authorized the test to use only for detecting RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection. It has not been authorized to be used for the detection of any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization 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 authorization is terminated or revoked sooner
About SARS-CoV-2 (coronavirus)
Coronaviruses (CoV) are a large family of viruses causing illness including common cold and more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not been identified in humans previously.
Signs of infection include respiratory symptoms such as cough, difficulty breathing, shortness of breath, and fever. In more severe cases, it can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.
For controlling the spread of the infection, it has been recommended by the WHO to regular wash hands, cover mouth and nose when coughing and sneezing, and avoid close contact with anyone showing symptoms of respiratory illness.
