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Roche receives FDA approval for companion diagnostic tests to identify patients with HER2 ...
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Medtech
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United States
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Fusion42 · 26 August 2026 · Fusion42 review
Roche has received FDA approval for companion diagnostic tests designed to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma who are eligible for treatment with ZIIHERA.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You now have a clearer route to market in US cancer diagnostics focused on HER2-positive metastatic gastroesophageal adenocarcinoma. Prioritise collaborations with Roche or access to their diagnostic tests to expand patient targeting in this niche.
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1 source · 26 Aug 2026
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MedtechFDA-approvaldiagnosticscancerHER2Roche