Tag Archives: cobas

August, 2018

23 August
FDA Approves Roche’s Cobas EGFR Mutation Test v2 as a Companion Diagnostic with Iressa

PLEASANTON, Calif., Aug. 23, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe …
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2 August
Roche’ Cobas HPV Test Receives FDA Approval for First-line Cervical Cancer Screening

TUCSON, Ariz., July 30, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for the cobas® HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens …
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19 October
FDA Approves Roche’s HBV and HCV Viral Load Tests

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HBV and cobas® HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas® 6800 and cobas® 8800 Systems. The fully automated …
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