Chromogranin A: Neuroendocrine Tumors

B·R·A·H·M·S CgA II KRYPTOR: the gold standard Chromogranin A test

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 to aid in 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.

Addressing key challenges in routine diagnostics for GEP-NETs

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

Short incubation time and less dilutions using the B·R·A·H·M·S KRYPTOR Analyzer for CgA assays3

 

Incubation time (min) of various CgA assays

Ratio of samples that require dilution in a representative clinical setting

Our solution: monitor Chromogranin A levels in neuroendocrine tumor patients with ease and confidence

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 gastroentero-pancreatic neuroendocrine tumors (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.

Clinical evidence: CASPAR (Chromogranin A Surveillance biomarker in Patients with Carcinoids)

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.

Helpful resources

Instructions for use: View B·R·A·H·M·S CgA II KRYPTOR IFU

Lab brochure: Learn more about CgA measurement for GEP-NETs on KRYPTOR

Product data sheet: Review specifications for the CgA II assay on KRYPTOR

References:

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.

  1. Lawrence B et al. Endocrinol Metab Clin North Am 2011; 40(1): 111 34
  2. Modlin IM et al. Ann Surg Oncol 2010;17(9): 2427 43
  3. Inman Z et al. Automated Chromogranin A: Is KRYPTOR the way to go? AACB Meeting 2012 Melbourne, Poster P85.

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KRYPTOR is a trademark of Cisbio Bioassays, licensed for use by B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific. Other product names in this document are used for identification purposes; they may be trademarks and/or registered trademarks of their respective companies.