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Roche announced Friday that the FDA issued an emergency-use authorisation (EUA) for the cobas SARS-CoV-2 test, which the company noted makes it the first commercial test for the virus in the US. The test is intended for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical or epidemiological criteria for testing.
According to Roche, hospitals and reference laboratories can run the test on the company's cobas 6800 and cobas 8800 systems, which it said are "widely available" in the US and around the world. The systems provide test results in 3.5 hours, with the cobas 6800 system able to provide a total of 1440 results in 24 hours, while the cobas 8800 system can produce 4128 results over the same period.
"We are increasing the speed definitely by a factor of 10," remarked Thomas Schinecker, CEO of Roche Diagnostics. The company noted that there are over 100 cobas 6800 and 8800 systems in the US, with a "significant amount" installed in recent weeks. "We definitely extended the capacity of the testing significantly throughout the US," Schinecker said, with the FDA noting that it authorised emergency use of the cobas SARS-CoV-2 test within 24 hours of receiving the application.
Roche indicated that 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. "Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA's granting of EUA supports our commitment to give more patients access to reliable diagnostics, which are crucial to combat this serious disease," said Schinecker.
Last month, the FDA authorised the emergency use of the US Centers for Disease Control and Prevention's real-time RT-PCR diagnostic panel for the novel coronavirus, while a diagnostic tool from the New York State Department of Public Health has also received this designation.
Alongside the EUA for the cobas SARS-CoV-2 test, the FDA announced Friday that the agency will not object to the New York State Department of Health (NYSDOH) authorising certain laboratories in New York to begin patient testing. The regulator noted that the move is "based on the urgent public health need for additional testing capacity."
FDA Commissioner Stephen Hahn commented "as a practical matter, what this action means is that labs, authorised by NYSDOH, will not engage with FDA to begin patient testing. Nor will they get an [EUA] from the FDA. These labs will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State."
Separately on Friday, the US Department of Health and Human Services unveiled a number of measures designed to tackle the COVID-19 outbreak, including the appointment of Brett Giroir to coordinate diagnostic testing efforts among Public Health Service agencies and increased support to diagnostic tests being developed by DiaSorin Molecular and Qiagen that may detect SARS-CoV-2 in approximately one hour.
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