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Roche passes US FDA's PMA approval for fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay.

M2 EQUITYBITES-June 26, 2017-Roche passes US FDA's PMA approval for fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay

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Pharmaceuticals company Roche (SIX:RO)(SIX:ROG)(OTCQX:RHHBY) reported on Friday the receipt of the US Food and Drug Administration's (FDA) PMA approval for its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay.

The company has received the US FDA approval for fourth-generation HIV combination antigen-antibody assay that allows detection of infection with high sensitivity and specificity as well as demonstrates commitment to improving efficiency by aiding labs in consolidating testing with other routine immunoassays

According to the company, the Elecsys HIV combi PT assay is for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2 in human serum and plasma. The assay may be used in the diagnosis of HIV-1/HIV-2 infection in subjects greater than two years of age and in pregnant women.

Intended for use as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute and primary HIV-1 infection, the company's fourth-generation HIV immunoassay is able to detect both antigen and antibodies simultaneously, increasing the likelihood of early detection of HIV infection, improving disease management as well as helping to prevent transmission of infection.

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Publication:M2 EquityBites (EQB)
Date:Jun 26, 2017
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