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Roche receives FDA approval for companion diagnostic tests to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA

The PATHWAY HER2 (4B5) test and VENTANA HER2 Dual ISH DNA Probe Cocktail help identify HER2-positive metastatic gastric, gastroesophageal junction and esophageal adenocarcinoma. Differential diagnosis of these cancers, often aggressive and diagnosed at an advanced stage, is critical to improving patient outcomes.

Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer's disease assessment across primary and specialty care

INDIANAPOLIS, Aug. 24, 2026 /PRNewswire/ -- Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test, providing clinicians across primary and specialty care with a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 years and older with signs, symptoms, or complaints of cognitive decline.4 Developed in collaboration with Eli Lilly and Company, Elecsys pTau217 is the first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.

Genentech Marks Topping out Milestone for New Holly Springs, North Carolina Manufacturing Facility

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)---- $RHHBY--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), today raised the final beam of its new manufacturing facility in Holly Springs, North Carolina, during a topping out ceremony – a construction milestone marking the completion of the manufacturing building's structural framework. The milestone reflects continued on-time progress on Genentech's approximately $2 billion investment in its first-ever East Coast manufacturing facility.