FDA Grants Emergency Use Authorization to Roche's High-Speed SARS-CoV-2 Diagnostic Test

March 15, 2020 News /BioValleyBIOON / — Swiss pharmaceutical giant Roche announced this Friday that one of its drugs, which can fasterDiagnosisNew Method for Novel Coronavirus Receives Emergency Approval from U.S. Regulators for Case Screening

Roche stated in a press release that the U.S. Food and Drug Administration (FDA) has approved the commercialization of the company’s SARS-CoV-2 test for detecting the virus that caused the global COVID-19 pandemic.

Roche stated that the test can be performed on a large scale using fully automated equipment, meaning it can deliver more results faster than other tests.

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RocheDiagnosisThomas Schinecker, head of the division, stated in an interview with Bloomberg News, “Our speed has definitely increased tenfold.”

Widespread testing is crucial in the race to control the spread of the virus. To date, the virus has infected more than 150,000 people and caused nearly 6,000 deaths worldwide.

Roche stated that its new assay will be launched in CE-marked markets in Europe, running on the widely used cobas 6800/8800 systems, and can deliver results within 3.5 hours. The largest system can provide results for up to 4,128 tests within 24 hours.

Schinecker stated in the declaration: "It is crucial to rapidly and reliably detect whether patients are infected with the virus." He also emphasized the need to accelerate the provision of reliableDiagnosisthe process is "crucial to combating this serious disease."

Roche stated that millions of tests would be available each month, and the company is committed to maximizing its production capacity to provide as many tests as possible. (Bioon.com)