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FDA approves Roche cobas Zika as first commercially-available donor screening test for Zika virus

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® Zika test for use on the cobas 6800/8800 Systems.

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Roche to initiate testing for Babesia parasite at U.S. Blood Centers under FDA Investigational New Drug Application protocol

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced immediate plans to initiate screening of blood samples with the cobas® Babesia test under an Investigational New Drug Application protocol.

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Roche expands Global Access Program to include the first fully automated CE marked nucleic acid HIV-1/HIV-2 qualitative diagnostic test

Roche announced today the expansion of the Global Access Program to include the cobas® HIV-1/HIV-2 for use on the fully automated cobas® 6800/8800 Systems. The test provides healthcare professionals with the ability to differentiate HIV-1 from HIV-2.

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Roche launches the first fully automated CE marked HIV-1/HIV-2 qualitative diagnostic test on cobas® 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of the cobas® HIV-1/HIV-2 for use on the automated cobas® 6800/8800 Systems in countries accepting the CE mark.

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Roche expands cobas® Liat® PCR System menu with launch of cobas® MRSA/SA test to target healthcare-associated infections

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of the cobas® MRSA/SA nucleic acid test for use on the cobas® Liat® System for the qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) at the point of care.

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Roche receives CE mark for CMV viral load testing on cobas® 4800 System

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of cobas® CMV (cytomegalovirus) for use on the automated cobas® 4800 System in countries accepting the CE mark.

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Roche receives FDA approval for CMV viral load testing on cobas® 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® CMV (cytomegalovirus) test for use on the fully automated cobas® 6800 and cobas® 8800 Systems.

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Roche launches cobas® Liat® PCR System with four assays into CE-markets

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff).

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Roche announces launch of cobas® HPV on the cobas® 6800/8800 Systems for cervical cancer screening in markets accepting the CE mark

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk.

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