Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.'s (NYSE: PFE) investigational drug PF-06946860.

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Roche Holding AG published this content on 08 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 February 2021 06:04:00 UTC.