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Wire · opportunities

Roche nabs expanded FDA approval for diagnostic tied to Jazz's cancer drug

27 August 2026 · By · Wire by Fusion42

Published

27 August 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at fiercebiotech.com →

◆ Verified

Fusion42 · 27 August 2026 · Fusion42 review

Roche has received expanded FDA approval for its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail diagnostic tests to identify HER2-positive metastatic gastroesophageal adenocarcinoma patients eligible for Jazz Pharmaceuticals' cancer drug Ziihera.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 26 Aug 2026 and 27 Aug 2026.

◆ ◆ The Wire takeaway

You can now expand patient targeting with diagnostics that unlock access to a newly approved cancer drug. If you work in oncology diagnostics, this FDA clearance opens a new door for companion tests tied to treatment eligibility.

◆ Coverage

2 sources · first reported 26 Aug 2026 · latest 27 Aug 2026

◆ Related on Wire

◆ Topics

Medtechfda-approvalcompanion-diagnosticoncologycancer-drugrochejazz-pharmaceuticals