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Roche (RHHBY) Announces Receipt of FDA Approval for cobas MPX Test

Go back to Roche (RHHBY) Announces Receipt of FDA Approval for cobas MPX Test

Roche receives FDA approval for fully automated blood screening assay on the cobasĀ® 6800/8800 Systems

October 21, 2016 3:04 PM EDT

PLEASANTON, Calif., Oct. 21, 2016 /PRNewswire/ -- 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® MPX test for use on the cobas® 6800 and 8800 Systems. The cobas® MPX test enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2 (HIV-1 and HIV-2), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through... More