Roche wins FDA approval for companion diagnostic to support breast cancer therapy

Photo credit: iStock via Getty Images. Article by Nick Paul Taylor. MedTech Dive – October 5, 2022.

Dive Brief:

• Roche has received approval from the Food and Drug Administration for the first companion diagnostic to identify patients with HER2-low metastatic breast cancer.
• U.S. officials first authorized the test in 2000. Now, Roche has added a scoring algorithm to help pathologists identify patients with breast cancers that express low levels of the HER2 receptor protein.
• The approval of Roche’s test comes two months after AstraZeneca and Daiichi Sankyo’s Enhertu became the first therapy authorized for use in HER2-low breast cancer in the U.S. […]

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