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

- Link: https://www.widthness.com/fda-clears-roche-diagnostic-for-astrazeneca-daiichis-breast-cancer-drug/
- Published: 2022-10-07T09:45:10-05:00
- Author: Curated by Theresa Wysocki

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. […] Click here to view original web page at www.biopharmadive.com