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NEW YORK – Roche announced Wednesday its Ventana HER2 Dual ISH DNA Probe Cocktail test received approval from the US Food and Drug Administration as a companion diagnostic for trastuzumab (Roche's Herceptin).

The test detects the human epidermal growth factor receptor 2 (HER2) biomarker in breast cancer and is meant to be completed within the same day, allowing for faster results than other HER2 testing methods. Results can also be read using light microscopy so there isn't a need for a specialized fluorescence microscope, Roche said in a statement. 

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.