
FDA Clears Thermo Fisher’s CgA Test for Rare Neuroendocrine Tumors
Thermo Fisher Scientific, a leading provider of scientific research services and diagnostics solutions, has received clearance from the U.S. Food and Drug Administration (FDA) for its Thermo Scientific B·R·A·H·M·S CgA II KRYPTOR immunoassay. This automated immunoassay is designed to assess tumor progression in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
GEP-NETs are rare tumors that originate from neuroendocrine cells and can develop in various parts of the gastrointestinal tract, including the pancreas. While they are considered uncommon, affecting 12,000 people per year in the U.S. annually, recent data from the National Cancer Institute has shown a significant increase of more than 500% in the incidence rate of GEP-NETs in the United States over the last three decades. The cancer has poor outcomes with a five-year survival rate of only 35%.
This newly cleared test allows laboratories and cancer centers to measure the concentration of chromogranin A (CgA) in human serum. Monitoring CgA levels enables healthcare providers to track the progression of the tumor and assess the effectiveness of treatment options. The FDA’s clearance of this assay means that it is now commercially available and can be consistently utilized in laboratories nationwide. This standardization is expected to enhance patient management and contribute to improved outcomes.
Tina Liedtky, President of Clinical Diagnostics at Thermo Fisher Scientific, emphasized the company’s commitment to developing clinical diagnostics solutions that empower healthcare providers to enhance patient outcomes. She stated that this assay will enable customers to replace manual laboratory-developed tests, boost lab productivity, and provide clear guidance for interpreting results.