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Thermo Fisher Announces FDA-clearance of First-to-Market Automated Assay to Assess Tumor Progression in Neuroendocrine Cancer Patients

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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 the first and only FDA-cleared chromogranin A (CgA) test and the only automated immunoassay worldwide for the assessment of tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.


GEP-NETs are derived from neuroendocrine cells that can form in the pancreas or in other parts of the gastrointestinal tract. Though these tumors are considered rare diseases, recent data from the National Cancer Institute’s Surveillance, Epidemiology and End Results Program shows a significant increase of more than 500% in the incident rate of this disease in the United States over the last three decades.

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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.


“Thermo Fisher is committed to the development of clinical diagnostics solutions that enable healthcare providers to improve patient outcomes,” said Tina Liedtky, president of clinical diagnostics at Thermo Fisher Scientific. “This assay will enable customers to replace manual laboratory developed tests, increase productivity in their labs, and will provide clear guidance on how to interpret results.”


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.