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

WALTHAM, Mass., Sept 25, 2023 – Thermo Fisher Scientific, the world leader in serving science, today 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.

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.

For more information on Thermo Fisher’s B·R·A·H·M·S CgA II KRYPTOR immunoassay, please visit:

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services throughour industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit:



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