ESA Introduces Clinical-Research Test Validated for Measurement of Choline in Whole Blood or Plasma

ESA Biosciences, a Magellan Biosciences company, announced today that it has developed an easy, fast, and specific choline test for research-use only – the first validated choline assay on the market suitable for use as a reference test and for large-scale clinical- and epidemiological-research studies. The 4.5 minute assay, which can be run on either the ESA Coulochem^® or CoulArray^® HPLC system, accurately quantitates choline in whole blood or plasma.

An essential nutrient that plays many key roles in the body, choline is gaining increased attention in the cardiology-research community due to its potential as a biomarker for screening and risk stratification of acute coronary syndrome (ACS). Increased choline concentrations have been associated with coronary plaque destabilization and tissue ischemia, two key components of the biochemical profile in ACS patients that are associated with increased risk of serious cardiac events. Comprehensive research is now needed to evaluate the use of choline measurements to further understand the underlying pathophysiology of ACS and to assess its clinical utility for detection of ischemia and prediction of adverse cardiac events in suspected cases of ACS.

Fast and accurate assessment of ACS is critical to health outcomes. In 2004, 1,236 Americans, on average, died each day of coronary heart disease. The following data from the National Center for Health Statistics (NCHS) further illustrate the medical need. Of the estimated six million US patient visits to the emergency room for chest pain in one year, two million cases resulted in discharge. In the other four million cases, patients remained in the ER for observation or were admitted to the hospital with suspected ACS. Nearly 65 percent of these “extended stay” patients were ultimately diagnosed with conditions other than ACS; however, the patient-screening process required significant medical resources to rule out serious cardiac events, typical of ACS. Perhaps more alarming is the human cost of missing ACS, thereby underestimating cardiac risk: NCHS cites 24,000 known cases of patients with chest pain that were misdiagnosed in the ER triage process. These patients were among the two million cases discharged from the ER after initial screening, but they actually had ACS! Doctors are looking for more-objective and predictive measures to enhance their clinical decision-making process.

In addition to cardiovascular disease, other pressing choline research topics include: its use as a potential therapeutic biomarker and in epidemiological studies to better understand choline as an essential nutrient. Choline deficiency has been associated with liver damage and its bioavailability is important in brain development of fetuses and newborns. Choline is also a precursor of acetylcholine, a neurotransmitter involved in muscle control, memory, and many other critical neurological functions.

While choline research has shown significant promise across many clinical and epidemiological applications, the lack of a fast, easy, and readily reproducible way to measure it has made it difficult for scientists to undertake the large-scale studies required to fully examine its potential as a clinical-diagnostic tool or as a nutritional or therapeutic biomarker. The ESA Choline HPLC Test changes all that, according to the company’s Vice President of Sales and Marketing, John Christensen: “Scientists have been asking for an off-the-shelf, validated laboratory assay that can deliver the reliable, reproducible results that this important research demands. We designed the Choline HPLC Test for simplicity, specificity, and speed – so researchers can focus precious resources on their study results – not on developing homebrew assays and methods.”

Mr. Christensen continued, “Sample preparation is easy with pre-packaged reagents for precipitation, internal standardization, and dilution of either whole blood or plasma samples prior to HPLC analysis. We obtain specificity through a combination of sample dilution, chromatographic separation, specific enzyme conversion, and selective electrochemical detection. The high-throughput test determines choline sample concentration by single-point calibration, enabling analysis time in fewer than 4.5 minutes. In addition, we validated this assay according to Clinical Laboratory Standards Institute (CLSI) guidelines, so researchers can count on the results assay to assay, experiment to experiment.”