FDA clears Thermo Fisher chromogranin A assay

November 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the concentration of chromogranin A in human serum. The biomarker is to be used in conjunction with other clinical methods as an aid in monitoring disease progression during the course of disease and treatment in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET), grades 1 and 2.

The assay is designed to run on the company’s Brahms Kryptor Compact Plus random-access immunoassay analyzer.

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