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FDA approves Roche’s high-volume immunoassay

4 May 2017 | By Niamh Marriott, Junior Editor

Roche’s new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyser series, the cobas e 801 module, has received 510(k) clearance from the US Food and Drug Administration (FDA). As core laboratories continue to evolve to meet the growing workload demands in an increasingly challenging environment, the cobas…

FDA approves Roche’s immunotherapy assay to support treatment decisions in lung cancer

31 October 2016 | By Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) has approved Roche’s PD-L1 assay as a diagnostic to identify PD-L1 expression levels in patients considering treatment with Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC)…