Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S CgA II KRYPTOR immunoassay. This is one of the first FDA-cleared chromogranin A (CgA) tests and one of the only automated immunoassays worldwide for the assessment of tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.
Using this new test, laboratories and cancer centers can measure the concentration of CgA in human serum, allowing them to track progression of the tumor and present options for evaluating the success of a treatment. With the FDA-clearance of this assay, customers will now have a commercially available test that can be deployed in a uniform way in laboratories across the country, ultimately helping improve patient management and support better outcomes.
This new assay is designed to run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS random-access immunoassay analyzer. Using TRACE technology, based on Nobel Prize winning chemistry, the analyzer can deliver highly accurate and precise results in less than 30 minutes.
For more information on Thermo Fisher’s B·R·A·H·M·S CgA II KRYPTOR immunoassay, please visit: www.thermofisher.com/chromogranin-a.