Roche Malaria Test Receives FDA Approval

Original from: 360dx

The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency. 

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The test qualitatively detects Plasmodium DNA and RNA in whole-blood samples from individual human donors and runs on the firm's molecular Cobas 6800/8800 instruments. The test detects DNA and RNA from P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi, according to a statement from the FDA. The assay is also intended for use in testing whole-blood samples to screen organ and tissue donors when samples are gathered while the donor's heart is still beating, FDA said. 

Roche's test isn't intended to help diagnose Plasmodium infection or for use with cord blood samples. The agency noted that this is the "first FDA-licensed test for screening blood donors for Plasmodium DNA and RNA in whole-blood samples to reduce the risk of transfusion-transmitted malaria."

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Source: Roche Malaria Test Receives FDA Approval