Roche (RHHBY) announced that the FDA has granted Emergency Use Authorization for the LightMix Ebola Zaire rRT-PCR Test.
The test is allowed for use in patients showing signs and symptoms of Ebola Zaire virus infection in combination with epidemiological risk factors, such as individuals traveling from West Africa.
The test is able to detect the Ebola Zaire virus in whole blood samples using the large installed base of Roche's LightCycler 480 or cobas z 480 instruments.
The FDA’s permission to use the molecular diagnostic test came on the heels of the recent widespread outbreak of the Ebola virus. As the test is equipped to rapidly detect presence of the virus, patient treatment may commence earlier than before.
Apart from providing therapeutic products and services for diverse medical needs, Roche focuses on innovative diagnostic solutions for the early detection and treatment of diseases.
This pharmaceutical major has a broad portfolio of diagnostic tests with more than a hundred high-quality Elecsys assays for immune testing along with a new generation of fully-automated cobas analyzers for better decision making, scheduling and efficiency. The Diagnostics division of the company generated sales of CHF 7.8 billion in the first nine months of 2014, up 6% from a year ago.
Roche is the exclusive distributor of the test. The test is not yet approved by the FDA but the agency has permitted to use the same considering increased need for such detection tests amid the Ebola epidemic.
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include AbbVie (ABBV), Allergan (AGN) and Abbott Inc (ABT). All three carry a Zacks Rank #2 (Buy).
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