Roche (RHHBY) said Monday that it has received 510(k) clearance from the U.S. Food and Drug Administration for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection, thus facilitating faster access to treatment. The clearance follows the assay's CE Mark approval in June 2024.
B-cell lymphoma is a type of cancer that typically develops in the lymphatic system. It accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases.
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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.