Yahoo Finance Roche's (RHHBY) Coronavirus Test Achieves EUA From the FDA
Roche RHHBY announced that the FDA issued an Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Test. The test will be used for the qualitative detection of SARS-CoV-2, the virus that causes the COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 and living in areas where the SARS-CoV-2 virus is known to be present.
The move comes at a time when there is an urgent need to quickly and reliably detect whether a patient is infected with SARS-CoV-2 as the World Health Organization describes the outbreak as a pandemic. The first commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs.
Moreover, testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity and provide results in three and a half hours, offering improved operating efficiency and flexibility.
COVID-19, a new strain of coronavirus, first appeared in late 2019 in China and causes severe pneumonia-like symptoms in infected patients.
Per reports, Roche’s anti-inflammation drug, Actemra (tocilizumab), was earlier approved in China to treat patients developing severe complications from coronavirus (COVID-19).
Given the outbreak of the disease, the spotlight is currently on the pharma/biotech companies, which are developing treatments/vaccines for the same. Big pharma companies like GlaxoSmithKline GSK and biotechs like Gilead Sciences, Inc. GILD, among others, are striving hard to develop vaccines and treatments to combat this deadly virus.
Roche also announced that the European Commission approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The combination regimen offers a new 12-month, fixed-duration, chemotherapy-free treatment option for adult patients with chronic lymphocytic leukemia. Venclyxto is being developed by the company in collaboration with AbbVie ABBV.
Roche’s stock has rallied 5.7% in the past year against the industry’s 10.2% decline.
The company’s efforts to broaden its pharmaceutical portfolio and concurrently develop the diagnostics portfolio have been impressive.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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