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Articles tagged with: Roche

FDA approves Roche’s alectinib product

Nov. 27, 2017—Roche announced that the FDA approved the supplemental new drug application for Alecensa (alectinib) for the treatment of …

Roche to acquire Viewics

Nov. 20, 2017—Roche announced today it will acquire Viewics, a privately held software company focused on laboratory business analytics. This …

FDA clears Roche panel for colorectal cancer

Nov. 14, 2017—Roche announced today FDA clearance of the Ventana MMR IHC Panel, which provides clinicians with a group of …

Roche gains CE mark for expanded use of PD-L1 assay,11/17

November 2017—Roche announced the expanded use of the Ventana PD-L1 (SP142) Assay in non-small cell lung cancer and metastatic urothelial carcinoma in CE markets in which the Roche cancer immunotherapy medicine Tecentriq is approved.

Roche to initiate testing for babesia parasite

Oct. 6, 2017—Roche announced immediate plans to initiate screening of blood samples with the Cobas Babesia test under an FDA …

FDA-approved tests for Roche instruments, 9/17

September 2017—Roche received FDA approval for the Cobas CMV test for use on its Cobas 6800 and Cobas 8800 Systems. The test is standardized to the 1st WHO International Standard for improving harmonization in cytomegalovirus testing results across hospital institutions.

Connecting Labs to Greater Medical Value:
How three hospitals are discovering new possibilities
with connected core labs

August 2017—The advent of the connected core lab is here, and labs of all sizes can take advantage of the unprecedented possibilities it affords. When they do, they’ll find that they have the power and the flexibility to meet the demands of today and the needs of tomorrow while delivering greater medical value across their healthcare systems.

Roche launches tissue dissection instrument

Aug. 15, 2017—Roche’s Avenio Millisect System, a tissue dissection instrument that utilizes an automated digitally assisted process to isolate clinically …

Cobas Liat PCR system with four assays, 7/17

July 2017—Roche announced the CE-IVD launch of the Cobas Liat PCR System with four assays, including a 20-minute real-time PCR nucleic acid test to detect Clostridium difficile.

Roche’s CDx assay FDA approved for Zykadia

June 19, 2017—The FDA approved Roche’s Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase–positive …