Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are tumors derived from neuroendocrine cells that can occur anywhere along the gastrointestinal tract. Chromogranin A (CgA) is a protein that is produced in high concentrations in endocrine and neuroendocrine cells, such as the pancreas, stomach, and intestines.1
CgA is released by GEP-NET cells and has been associated with increased tumor burden, therefore the measurement of CgA is considered a gold standard of biochemical tests to track progression of tumor disease and presents options for evaluating the success of a treatment.2
Currently, for patients with GEP-NETs, the applied routine diagnostic tools are clinical assessment supported by lab-developed manual immunoassays testing and imaging methods such as CT/MRI.
Key challenges in routine diagnostics
Manual lab developed tests (LDTs) require heavy intervention and hands-on processes, resulting in inefficient lab workflow
High maintenance associated with CgA LDTs and the necessary analytical performance checks and related responsibilities
Heterogeneous quality of available CgA LDTs often leads to incomparable results
Long processing time associated with sending in CgA measurements via LDT
|Manual lab developed tests (LDTs) require heavy intervention and hands-on processes, resulting in inefficient lab workflow
|High maintenance associated with CgA LDTs and the necessary analytical performance checks and related responsibilities
|Heterogeneous quality of available CgA LDTs often leads to incomparable results
|Long processing time associated with sending in CgA measurements via LDT
Thermo Scientific™ B·R·A·H·M·S™ CgA II KRYPTOR™ is the first FDA-cleared, 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 GEP-NETs, grade 1 and grade 2.
Availability of B·R·A·H·M·S CgA II KRYPTOR in clinical reference or private labs and cancer centers could fully replace manual LDTs, increase productivity in labs, and provide clear guidance on how to interpret results.
Fast time to results
|Fast time to results
A prospective, multi-center, observational study with 153 evaluable neuroendocrine tumor patients was performed to validate the performance of B·R·A·H·M·S CgA II KRYPTOR assay in monitoring grade 1 and grade 2 GEP-NET progressive or non-progressive disease within 32 months.
Course of disease was assessed by standard imaging (CT/MRI scans) and tumors were classified by RECIST 1.1 criteria for progression (progressive disease) vs. no progression (complete response, partial response or stable disease). The change in CgA levels between visits was considered positive if the CgA concentration increased by more than 50% to an absolute value of >100 ng/ml.
Exceptionally precise, fast and easy
The Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS automated random access immunoanalyzer is a user-friendly bench-top instrument that can easily be integrated into any laboratory.
A comprehensive summary of performance can be found in the Instructions for Use for each assay or in the User Manual of your B•R•A•H•M•S KRYPTOR instrument.