The novel blood biomarker Copeptin is now available for clinical use in early rule-out of acute myocardial infarction and diagnosing water balance disorders

B·R·A·H·M·S Copeptin proAVP KRYPTOR has been registered in Canada allowing for faster, more reliable indirect measurement of vasopressin to improve diagnostic algorithms

HENNIGSDORF, GERMANY – May 23, 2019 – As laboratories and clinicians increasingly look to determine key biomarkers to aid therapy decisions and support a timely diagnostic work-up to better manage overcrowded emergency departments, Canadian doctors can now order the B·R·A·H·M·S Copeptin proAVP KRYPTOR immunoassay for the determination of C-terminal pro vasopressin (CT-proAVP, also known as Copeptin). The biomarker test was recently registered by Health Canada and can be analyzed in human serum and human plasma using the B·R·A·H·M·S KRYPTOR laboratory instruments.

Based on “The Biomarkers in Cardiology” (BIC)-8, the first interventional clinical trial in the cardiac biomarker field, B·R·A·H·M·S Copeptin proAVP KRYPTOR immunoassay in conjunction with troponin testing demonstrate a safe and early rule-out of patients with suspected acute myocardial infarction (AMI) at the first blood draw. A second study (cost analysis) considered clinical data taken from BIC-8 trial from an economic perspective. Combined, both studies suggest that early rule-out of AMI is safe and can directly translate into economic value for the entire hospital setting. The B·R·A·H·M·S Copeptin proAVP KRYPTOR assay is indicated as an aid to be used in conjunction with cardiac troponin and the clinical evaluation in ruling out acute myocardial infarction in patients presenting wich chest pain or equivalent symptoms of cardiac origin in a hospital setting.

In addition to the early rule-out of AMI, the Copeptin test also helps doctors in the differential diagnosis of patients with water balance disorders, e.g. polyuria-polydipsia syndrome or syndrome of inappropriate ADH secretion (SIADH) in an outpatient and hospital setting. A recent study published in the New England Journal of Medicine (2018) concluded that the measurement of Copeptin had a greater diagnostic accuracy than the classic water-deprivation test.

About Copeptin

Copeptin, part of the vasopressin prohormone, is a marker of the individual hemodynamic stress response. Arginine vasopressin (AVP) is a key hormone in the human body. Despite the clinical relevance of AVP in maintaining fluid balance and vascular tone, measurement of mature AVP is difficult and subject to pre-analytical errors. Copeptin, a 39-amino acid glycopeptide that comprises the C-terminal part of the AVP precursor (CT-proAVP), has been found to be a stable and sensitive surrogate marker for AVP, analogous to C-peptide for insulin. Copeptin measurement has been shown to be useful in various clinical indications, circulating Copeptin levels rise to peak values rapidly and then decline over the next hours. The pre-pro-vasopressin precursor is synthesized and processed into its three components – AVP, Neurophysin II, and Copeptin – within the hypothalamus; afterward, these products are transported along the neuronal axons in the granules of the posterior hypophysis (pituitary gland), where they are stored and released under the appropriate stimulus.

Thermo Scientific B·R·A·H·M·S Copeptin proAVP KRYPTOR immunoassay is part of a series of biomarker assays which can be used in cardiology and endocrinology. For more information, please see the following site: www.thermoscientific.com/copeptin

Product is CE marked but not 510(k)-cleared and not available for sale in the U.S. Availability of product in each country depends on local regulatory marketing authorization status.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.

 

References

  1. Möckel M, Searle J, Hamm C, et al. Early discharge using single cardiac troponin and copeptin testing in patients with the suspected acute coronary syndrome (ACS): a randomized, controlled clinical process Eur Heart J (2015) 36, 369-376. doi:10.1093/eurheartj/ehu178
  2. Reinhold T, Giannitsis E, Moeckel M, Frankenstein L, Vafaie M, Vollert JO, et al. Cost analysis of early discharge using combined copeptin/cardiac troponin testing versus serial cardiac troponin testing in patients with the suspected acute coronary syndrome. PLoS ONE 13(8): e0202133. (2018)doi.org/10.1371/journal.pone.0202133
  3. Fenske W, Refardt J, Chifu I, et al. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med (2018); 379379:428-39. doi:10.1056/NEJMoa1803760

 

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