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Quest Diagnostics Incorporated (NYSE: DGX) today announced results of a study that demonstrates that a novel diagnostic testing technique it has developed is the first to provide direct, accurate and reproducible physical measurement of both the size and concentration of a broad range of lipoproteins in blood plasma. Results of the study were published in the May 29, 2008, online edition of Clinical Chemistry.
"Our data suggest that this novel ion mobility-based method offers advantages over other procedures for lipoprotein particle analysis because it both measures particle size accurately on the basis of physical principles as well as directly counts the particles present at each size independently of particle composition. We believe this approach provides the only direct physical measurement of lipoprotein particle size and concentration for each lipoprotein subclass, from small HDL to large VLDL," said Richard E. Reitz, MD, co-lead investigator and acting vice president, Science and Innovation, and medical director, Quest Diagnostics Nichols Institute. "We look forward to learning the results of additional research to identify the technique's clinical utility for risk assessment and treatment in patients with cardiovascular disease and related conditions."
Lipoprotein particles are fatty substances carried through the blood stream that affect cardiovascular health. High-density lipoproteins (HDL), referred to as "good" cholesterol, promote healthy cardiovascular function, but LDL and very-low density lipoproteins (VLDL), or "bad" cholesterol, may deposit on the walls of arteries, promoting atherosclerosis and other cardiovascular diseases. Because particles of LDL, intermediate-density lipoprotein (IDL) and VLDL each contain one apolipoprotein B (ApoB) protein, ApoB concentration may give a better indication of large lipoprotein particle concentration than measurements of cholesterol concentrations alone(1). The American Diabetes Association and American College of Cardiology Foundation recently published a consensus statement that recommends physicians use ApoB measurements to guide therapy in individuals with cardiometabolic risk who are on statin therapy(2). Yet, clinically available methods of measuring lipoprotein particle subpopulations are not standardized and generally use an algorithm to indirectly measure lipoprotein particle concentrations.
The objective of the study, conducted by Quest Diagnostics Nichols Institute, was to describe and validate the ability of the ion mobility technique to directly and accurately measure plasma lipoprotein particles, covering the spectrum of HDL, LDL, IDL and VLDL in healthy adults. Approximately 260 healthy male and female adults who met the National Cholesterol Education Program's Adult Treatment Panel III guidelines for optimal plasma lipid and lipoprotein concentrations were recruited to establish reference distributions for the lipoprotein fractions detected by the method. Concentrations of total HDL, HDL Large, total LDL, total IDL, total VLDL, and non-HDL particles were determined using the ion mobility technique and correlated with biochemical measurements of calculated triglycerides, HDL cholesterol, LDL cholesterol as well as plasma ApoA1 and ApoB.
Results showed that the ion mobility technique was very precise in measuring LDL particle size, producing a variation of less than one percent over approximately 48 preparations of the same sample. The HDL and LDL concentrations varied less than 20 percent in these same preparations. The study also found a strong correlation (r=0.92) between the non-HDL (LDL, IDL and VLDL combined) concentration and the plasma concentration of ApoB, the single protein present in all non-HDL particles. The strong correlation of ApoB with non-HDL particles using the ion mobility technique was expected, as both provide measurements of lipoprotein concentration. The comparatively poorer correlation with cholesterol reflects the varying concentrations of this compound within lipoprotein particles, underscoring the ion mobility technique's potentially unique advantage over other methods. Specifically, while other techniques generally depend on cholesterol measurements to determine particle concentration, the ion mobility method measures lipoprotein particle concentration and size regardless of the particle's lipid, protein, triglyceride and cholesterol content.
Quest Diagnostics funded the study, which is titled "Direct Determination of Lipoprotein Particle Sizes and Concentrations by Ion Mobility Analysis." Results of the study are now available at: http://www.clinchem.org/cgi/content/abstract/clinchem.2007.100586.
Independent researchers expect this year to complete their review of an outcomes study designed to determine if the technique provides clinically useful information for predicting and monitoring cardiovascular disease in patients.
"While more research and development is required, we are excited by the findings of our analytical research, which clearly demonstrates that our ion mobility technique can measure particle size and concentrations using a direct, rather than algorithm-based method," said Michael P. Caulfield, PhD, scientific director, Research and Development, Endocrinology, Quest Diagnostics Nichols Institute, and one of the study's investigators. "Depending on the results of the third-party outcomes study, we are optimistic that our ion mobility technique will provide the basis for developing a high- throughput standardized diagnostic test that will enable physicians to more accurately understand the unique lipoprotein characteristics of the individual patient."
The new technique uses the principles of ion mobility to provide direct measurement of particles. Ion mobility determines particle size based on the drift velocity of ion-charged particles as they pass through a layer of air under the force of an electric field. Ion mobility, which is commonly used to analyze aerosols, is employed in nanotechnology, proteomics and drug development. In 2004, Quest Diagnostics co-exclusively licensed certain ion mobility patents for lipoprotein analysis from Ernest Orlando Lawrence Berkeley National Laboratory ("Berkeley Lab") in Berkeley, CA, and subsequently utilized the patent rights to develop its own test. Quest Diagnostics now has two patents pending for further technological advances.
In addition to Dr. Reitz, Ronald M. Krauss, MD, director of Atherosclerosis Research, the Children's Hospital Research Institute (CHORI), Oakland, CA, was a co-lead investigator on the study. Dr. Krauss co-developed the original patent while a senior scientist in the Life Sciences Division of Berkeley Lab.
Quest Diagnostics is a leader in cardiovascular disease diagnostics. In 1999, the company became the first diagnostic company to offer a high- sensitivity C-reactive protein (CRP) test cleared by the U.S. Food and Drug Administration for cardiac risk stratification. The Cardio CRP test helps physicians assess the risk a patient may have a heart attack based on CRP levels and other factors. Quest Diagnostics was also one of the first diagnostic companies to provide lipid-panel test results that provide directly reported, rather than indirectly calculated, LDL levels for patients whose triglyceride levels are more than 400 mg/dl. Triglyceride levels above 400 mg/dl can cause LDL levels to reflect measurements at levels lower than they actually are, putting some patients at risk for under treatment.
About Cardiovascular Disease
Cardiovascular disease refers to a group of diseases that involve the heart or blood vessels and which have similar causes. These include hypertension, atherosclerosis, heart attack and stroke, among others. Approximately 81 million Americans, or one in three, have one or more cardiovascular diseases, according to the American Heart Association. In many patients, cardiovascular disease progresses over the course of years, even decades, before heart problems are detected. The National Cholesterol Education Program recommends a blood test at least once every five years in all adults to measure total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. If a patient's total and LDL cholesterol is too high, a physician may recommend lifestyle changes and medication to bring the levels within a healthy range.
About Lawrence Berkeley National Laboratory
Berkeley Lab is a U.S. Department of Energy national laboratory located in Berkeley, California. It conducts unclassified scientific research and is managed by the University of California. Visit the Lab website at http://www.lbl.gov.
About Research at Children's Hospital & Research Center
Research efforts at Children's Hospital & Research Center Oakland are coordinated through Children's Hospital Oakland Research Institute (CHORI). CHORI was founded in 1970. The Institute supports basic and clinical research to improve treatment and prevent illness in children and adults locally and globally. CHORI links science and patient care through shared goals, strategic planning, co-recruitment, and fostering translational and clinical research. Nationally, the Institute is ranked in the top ten percent of Children's Hospitals and the top 6 of Departments of Pediatrics based upon NIH funding. Its outstanding faculty benefit from the academic freedom, supportive environment, affiliations with the University of California and entrepreneurial spirit that characterize the Institute. CHORI has approximately 300 staff members and an annual budget of more than $50 million. The Institute is a leader in translational research, bringing bench discoveries to bedside applications. These include providing cures for blood diseases, developing new vaccines for infectious diseases and discovering new treatment protocols for previously fatal or debilitating conditions such as cancers, sickle cell disease and thalassemia, diabetes, asthma, HIV/AIDS, pediatric obesity, nutritional deficiencies, birth defects, hemophilia and cystic fibrosis.
About Quest Diagnostics Incorporated
Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.questdiagnostics.com.
The statements in this press release that are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results and outcomes to be materially different. Certain of these risks and uncertainties may include, but are not limited to, competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners and other factors described in the Quest Diagnostics Incorporated 2007 Form 10-K and subsequent SEC filings.
(1) THE LANCET, Vol 361, March 1, 2003
(2) DIABETES CARE, VOLUME 31, NUMBER 4, APRIL 2008
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