Roche Gets FDA Nod for Emergency Use of Zika Virus Test

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Roche Holdings RHHBY announced that the FDA has issued an Emergency Use Authorization (EUA) for its LightMix Zika rRT-PCR Test.

Note that the test has, however, not been cleared or approved by the FDA yet. The agency has only allowed its use under the EUA criteria. In other words, it is authorized for use only if circumstances justify emergency use of in vitro diagnostics for the detection of Zika virus. At present, the widespread outbreak of the virus underscores urgent need for tests to detect and diagnose the same.

This easy-to-use molecular diagnostic test will allow physicians to quickly detect the virus in affected patients. The test can be used in patients meeting the CDC Zika virus clinical criteria and/or the CDC Zika virus epidemiological criteria. It can be used for the detection of Zika virus in EDTA plasma or serum samples using Roche's LightCycler 480 Instrument II or cobas z 480 Analyzer.

Additionally, Roche has developed the cobas Zika Test for use with the cobas 6800/8800 Systems. However, this test is available only under an Investigational New Drug Application (IND) protocol to initiate collection and testing of blood samples for screening. Blood centers in the U.S. are currently using this test to screen samples.

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Roche specializes in developing drugs for oncology, immunology and infectious diseases. Apart from providing therapeutic products and services for diverse medical needs, the company focuses on innovative diagnostic solutions for the early detection and treatment of diseases. The company also leads the vitro diagnostics and tissue-based cancer diagnostics markets. Approval of new tests will strengthen its diagnostic division which is currently facing challenging conditions in the form of pricing and reimbursement issues in the diabetes care business.

Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked health care stocks include Pacira Pharmaceuticals, Inc. PCRX, Corcept Therapeutics Incorporated CORT and ANI Pharmaceuticals, Inc. ANIP. Each of these stocks sports a Zacks Rank #1 (Strong Buy).

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