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Roche secures CE mark for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0.

M2 PHARMA-February 18, 2014-Roche secures CE mark for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0


18 February 2014 - Swiss Roche (VTX:ROG; OTCMKTS:RHHBY) said Tuesday that its COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0, had obtained the CE mark.

The in-vitro diagnostic, total nucleic acid amplification test amplifies and identifies at the same time two separate regions of the Human Immunodeficiency Virus Type 1 (HIV-1) genome, which are not subject to selective drug pressure. This dual target design enables delivery of more reliable data for diagnosis of HIV-1 infection.

The product uses both plasma and dried blood spot (DBS) collection cards to ease PCR testing, as well as facilitates sample collection and transportation. This is expected to increase access to the test for infants and adults across Africa.

The assay utilises the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer for automated amplification and detection.

It has been estimated that 35 million people worldwide had HIV infection as of 2012, according to data by the World Health Organization (WHO). That same year, 2.5 million people became newly infected with HIV globally.

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Publication:M2 Pharma
Date:Feb 18, 2014
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