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Use serum Chromogranin A (CgA) on Thermo Scientific B·R·A·H·M·S KRYPTOR instruments as a tool in early detection of prostate cancer transition during monitoring of all your patients under hormonal therapy.
Prostate cancer is one of the most prevalent cancers in men worldwide.¹ Neuroendocrine prostate cancer (NEPC) is an aggressive subtype of prostate cancer characterized by neuroendocrine differentiated cells.
Castration resistant prostate cancer (CRPC) requires a change of therapy. Therefore, monitoring is necessary to detect neuroendocrine differentiation, treatment-emergent resistance to ADT, and risk of progression.
The fully automated immunoassay for Chromogranin A is not only indicated in neuroendocrine tumors but also provides a tool to aid in therapeutic monitoring to identify patients with neuroendocrine differentiated prostate cancer and ADT resistance.
Prostate specific antigen (PSA) is the most important biomarker to monitor prostate cancer patients. However, NEPC cells secrete no or only low amounts of PSA. Nevertheless, CgA is expressed by NEPC cells and secreted directly into circulation.2,3 This leads to an increase of CgA levels in blood which could therefore indicate NEPC earlier than PSA alone.
NEPC cells are able to grow independently from androgens. Standard androgen deprivation therapies
(ADTs) are therefore no longer effective against these cancer cells. CgA is an aid in earlier identification of emerging resistance to hormonal therapy because of simple detection in the blood.4,5
Therapy needs to be changed in patients with ADT resistant prostate cancer to either advanced
hormonal treatments (e.g. Abiraterone, Enzalutamide) or chemo-therapy. CgA values are associated with therapy response and thus help in therapy decisions.6
For monitoring of NEPC, prostate-specific antigen is of limited use as it is usually not expressed by
neuroendocrine cells. In contrast, these cells do express CgA, which correlates with tumor stage and
progression of disease, providing important additional information to urologists and oncologists.2,6
By providing an aid for a better guidance in the treatment and more confidence in the monitoring of
NEPC, CgA enables urologists and oncologists to improve the overall care of the patient.6,7,8
The inclusion of the CgA assay in the updated German guidelines on Prostate Cancer management9 reflects the growing recognition of its clinical relevance in the management of this disease. Recent publications support the inclusion of these new recommendations.10 ,11
By incorporating the CgA assay into the guidelines, German healthcare professionals will have an additional tool to aid in treatment decision-making for patients with neuroendocrine prostate cancer. This development reinforces the importance of staying up to date with the latest guidelines and advancements in the field of oncology/urology.
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.
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.
Short incubation time and less dilutions using the B·R·A·H·M·S KRYPTOR Analyzer for CgA assays12
Incubation time (min) of various CgA assays
Ratio of samples that require dilution in a representative clinical setting
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.
Thermo Fisher Scientific products are distributed globally and their uses, applications, indications, claims and availability of products in each country depend on local regulatory marketing authorization status, please consult the Instructions For Use (IFU) available in your country.
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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.