HDL, Inc. Announces Development and Availability of First Lipoprotein(a) Particle Concentration Assay

New, modern assay, suitable for use in cardiovascular risk assessment, measures lipoprotein(a) particle concentration rather than more common mass or cholesterol
RICHMOND, VA (FEBRUARY 18, 2015) – Researchers at Health Diagnostic Laboratory, Inc. (HDL, Inc.) have developed a novel, proprietary method to measure atherogenic lipoprotein(a) particle concentration [Lp(a)-P]. The new method relies on modern immuno-electrophoretic techniques that separate and identify particles based on their charge and size, as opposed to current assays that measure either the amount of cholesterol contained in the Lp(a) fraction or, more commonly, the total mass of the Lp(a) particles in the circulation.
“Once considered too imprecise for lipoprotein analysis, developments during recent decades in electrophoretic technology have now been brought to bear on the analysis of lipoproteins, achieving a level of accuracy and precision not thought possible in the past,” said Philip Guadagno, MS, an internationally-recognized expert on electrophoresis, senior scientist at HDL, Inc., and part of a team that developed and validated the new Lp(a) method.

Guadagno is lead author on a paper describing the assay’s invention in the January 2015 issue of Clinica Chimica Acta, a major international clinical chemistry journal. The method is known as lipoprotein immunofixation electrophoresis, or Lipo-IFE. 

Lp(a) is the most atherogenic of all lipoproteins. Its levels in the serum vary wildly between individuals and are strongly genetically determined. Although there are, as yet, no drugs approved to specifically lower Lp(a) levels, knowledge of its serum concentration can help determine a patient’s cardiovascular risk status, which can in turn guide the intensity of therapy used to control other risk factors. Drugs which are effective in decreasing the atherogenic Lp(a), including specificity for Lp(a), are in development and expected to be available in the near term.

Lp(a) particles are similar to LDL particles, except that they carry an additional protein called apolipoprotein(a), or apo(a), a polypeptide comprising multiple repeated loop domains, or “kringles.” Because the number of kringles can vary by individual, it has been very difficult to accurately measure its true serum level in terms of numbers of Lp(a) particles. The new Lp(a) assay from HDL, Inc. is the first commercial assay that is truly insensitive to variations in apo(a) isoform size. 

Current methods of Lp(a) measurement are based on the use of selective antibodies to detect Lp(a), as is done for low- and high-density lipoproteins, LDL-C and HDL-C. However, both Lp(a) mass and Lp(a) cholesterol can vary substantially among individuals who have the same number of Lp(a) particles per unit of serum, due to the wide variations in apo(a) size and/or cholesterol content of the particles. Since LDL- and HDL-attributable cardiovascular risk is most robustly predicted by their particle concentrations, the same is likely to be true for Lp(a). However, without a method to determine this measure, the question has not been answerable – until now. 

“With this breakthrough in Lp(a) analytical methodology, we are finally able to assess Lp(a) particle concentrations – which we think can be more powerful than Lp(a) mass or cholesterol – as predictors of cardiovascular risk,” said Joseph McConnell, PhD, senior author of the paper and President and CEO of HDL, Inc. 

The paper, “Validation of Lipoprotein(a) Particle Concentration Assay by Quantitative Lipoprotein Immunofixation Electrophoresis,” is available online here: http://www.sciencedirect.com/science/article/pii/S0009898114004446. In addition to Guadagno and McConnell, the authors include Erin G. Summers Bellin, BS; William S. Harris, Ph.D.; Thomas D. Dayspring, MD; Daniel M. Hoefner, Ph.D.; Dawn L. Thiselton, Ph.D.; Brant Stanovick, BS; and G. Russell Warnick, MS. 

About Health Diagnostic Laboratory, Inc.
Founded in 2008, Health Diagnostic Laboratory, Inc. (HDL, Inc.) is a leader in health management with one mission: prevent and reverse heart disease and diabetes, one patient at a time. The company offers a comprehensive test menu of biomarkers that can indicate risk for cardiovascular disease, diabetes, and related diseases. HDL, Inc.’s systematic approach identifies factors contributing to disease and provides a basis for effective treatment, allowing healthcare providers to more effectively manage their patients. In addition to lab testing, HDL, Inc. offers patients a personalized overview of risk factors and assistance from expert Clinical Health Consultants to promote healthy, longer-lasting lifestyles. The company also provides comprehensive testing and wellness services to employers and is a partner for value-based, integrated care models and health systems. HDL, Inc. is a CLIA-certified, CAP-accredited laboratory. For more information, visit myHDL.com, and make HDL, Inc. part of your digital lifestyle at Facebook.com/myhdl and on Twitter @hdltweets.

MEDIA CONTACT: Jeff Kelley / Director of Marketing and Public Relations / 804.370.3257 / jkelley@hdlabinc.com

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