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Roche expands indication for cobas® EGFR Mutation Test v2 as a companion diagnostic with TAGRISSO®

  New indication as a companion diagnostic with AstraZeneca’s TAGRISSO® (osimertinib) in first line treatment of patients with non-small cell lung cancer (NSCLC) Results for EGFR mutations can be available in less than one day with the cobas® EGFR Mutation …

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Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems

Roche announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas® CT/NG for use on the cobas® 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.

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Roche receives FDA clearance for Factor II and Factor V test on the cobas® 4800 system

Roche announced today that it has received FDA clearance for the cobas® Factor II and Factor V Test for use on the cobas® 4800 system. The test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia.

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Roche launches cobas TV/MG on the cobas 6800/8800 Systems in markets accepting the CE mark

Roche today announced the CE-IVD launch of cobas® TV/MG, for use on the cobas 6800/8800 Systems for the direct detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic individuals.

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Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas

  New technology allows better testing and monitoring of HIV patients living in remote settings For the first time, patient plasma samples no longer need refrigeration during transport to the lab Card meets the World Health Organization sensitivity requirement for …

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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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