FDA approves Roche's faster Herceptin companion test

By LabPulse.com staff writers

July 31, 2020 -- The U.S. Food and Drug Administration has granted approval to Roche's new Ventana dual in situ hybridization (ISH) companion diagnostic, for use with the company's well-established HER2-targeted drug trastuzumab (Herceptin).

Roche created the Ventana HER2 Dual ISH DNA Probe Cocktail assay to work with the Ventana Silver ISH and the Ventana Red ISH kits on the automated BenchMark Ultra. It is a newer version of a previous-generation test that offers high-quality staining with improved turnaround time, according to the company.

The test is designed for same-day completion and the results can be read using light microscopy instead of fluorescence microscopy, Roche said.

Roche's strong COVID-19 test sales help offset losses in routine screens
Strong performance in Roche's molecular diagnostics business -- COVID-19 tests in particular -- for the first half of the year helped offset losses for...
Roche partners with cancer network for personalized care
Roche has partnered with Summit Cancer Centers to help personalize cancer care for patients at Summit's integrated cancer treatment centers in eastern...
Roche wins FDA nod for follicular lymphoma mutation test
Roche has garnered U.S. Food and Drug Administration (FDA) approval for its cobas EZH2 mutation test in follicular lymphoma patients.
Roche IL-6 test cleared, identifies high-risk COVID-19 patients
Roche's Elecsys interleukin-6 (IL-6) test has received authorization for emergency use from the U.S. Food and Drug Administration as a method for identifying...
U.K. contracts with Roche, Abbott for more than 10M antibody tests
The U.K. government has contracted with Roche and Abbott Diagnostics to provide more than 10 million coronavirus antibody tests as part of a new...

Copyright © 2020 LabPulse.com

Last Updated ls 7/31/2020 8:34:20 AM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.