News

Loading...

FDA Grants Roche Label Extension for the cobas® EGFR Mutation Test v2 for use with Plasma as a Companion Diagnostic for TAGRISSO™

Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas® EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s …

Explore

Roche receives FDA Emergency Use Authorization for Zika PCR test

Roche today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the LightMix® Zika rRT-PCR Test.

Explore

Roche receives CLIA waiver for cobas® Influenza A/B & RSV test for the cobas® Liat®

The first CLIA-waived, real-time PCR test that differentiates flu and RSV in 20 minutes is available now for use in physician offices and urgent care settings.

Explore

Roche HIV Global Access Program expands to include next-generation automated platform solutions

High throughput cobas® systems help optimize workflow for resource-limited settings Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion…

Explore

Roche Receives FDA Approval for Use of SurePath Preservative Fluid with cobas HPV Test for Cervical Cancer Screening

Roche HPV test is first to be approved for use with the SurePath Preservative Fluid gynecologic cell collection…

Explore

Roche announces availability of the LightMix Modular Zika Virus Assay (CE) in markets accepting the CE mark

Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB MOLBIOL, GmbH, announced today the availability of the LightMix Modular Zika Virus…

Explore

FDA Grants First Liquid Biopsy Approval to the Roche cobas® EGFR Mutation Test v2

Test can be used with either plasma or tumor tissue, as a companion diagnostic for non-small cell lung cancer therapy.

Explore

Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients

New test standardizes CMV testing for both solid organ and hematopoietic stem cell transplant recipients.

Explore
Loading...