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Roche gets FDA approval for HER2 breast cancer diagnostic

October 4, 2022

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The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 million new cases each year, and each year over 620,000 breast cancer patients will die.

Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test becomes the only FDA approved companion diagnostic indicated to aid assessment of HER2 low-metastatic breast cancer patients.

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