OXIDIZED LDL (oxLDL) FOR THE DIAGNOSIS AND THERAPEUTIC MONITORING OF CHRONIC CORONARY ARTERY DISEASE (CAD)
- Well documented studies demonstrate that oxLDL is the most accurate biomarker for chronic CAD.
- Directly involved in the development and progression of atherosclerotic plaque.
- Only blood test to reflect disease activity in the artery wall.
- Prognostic marker of atherosclerotic process.
- Standard specimen collection (EDTA-lavender-top tube) and handling. Does not require fasting.
- Clinically proven, next generation test for CAD.
- Marketing objective equals current Total Cholesterol volumes.
MALONDIALDEHYDE (MDA)-MODIFIED LDL FOR THE DIAGNOSIS OF ACUTE CAD
- Fully oxidized LDL found in atherosclerotic plaque is termed malondialdehyde (MDA)-modified LDL.
- Found in the blood stream only when plaque becomes unstable and rupture exposes MDA-modified LDL.
- Elevated in patients with unstable angina and acute myocardial infarction (MI).
- May play a major role in a series of diseases resulting from damage to small blood vessels and tissue.
- Studies by the University of Leuven require further evaluation.
NSI HAS EXCLUSIVE RIGHTS FOR OXIDIZED LDL AND MDA-MODIFIED LDL
- Research and development performed by University of Leuven.
- Key personnel are Dr. Desire Collen and Dr. Paul Holvoet.
- Dr. Desire Collen’s research group developed Tissue Plasminogen Activator (t-PA), the leading treatment for heart attacks and strokes.
PATENTS – APPROVED AND PENDING
Following patents to be issued in the US, Canada, Europe, Japan, Australia, New Zealand:
“Assays, Antibodies and Standards for Detection of Oxidized LDL and MDA Modified LDL.” US 7,390,627
“Detection and Determination of the Stages of Coronary Artery Disease.” US 6,309,888
“Detection of Asymptomatic CAD Using Atherogenic Proteins and Acute Phase Reactants.” US 2005/0181251 A1
KEY ANTIBODIES DEVELOPED BY THE UNIVERSITY OF LEUVEN, BELGIUM
OxLDL and MDA-modified LDL antibodies developed by the University of Leuven target a conformational epitope in the Apo B-100 moiety that is generated by substitution of the lysine residues of Apo B-100. The US patent 7,390,627 referenced above provides further description. Other research papers and abstracts use antibodies that target epitopes in the phospholipids surrounding LDL and HDL molecules.
STATUS OF ASSAY – TEST KITS ARE AVAILABLE FOR CLINICAL USE
In May 1999, NSI sublicensed Mercodia AB in Uppsala, Sweden to develop microtiter plate assays for commercialization worldwide. Some 400 articles/posters using the Mercodia assays have been published. Semi-exclusive sublicenses have been issued to one major diagnostic company for point-of care testing and one major company for application to their automated platforms. One additional sublicense is planned for each of the two categories. Shiel Medical Laboratory is now offering the oxLDL test to physicians in the New York metropolitan area and throughout the United States. Further information is available at www.shiel.com.
SUBSTANTIAL MARKET POTENTIAL
- One million Americans die each year due to cardiovascular disease (about one half of all deaths).
- Some 20 million Americans take cholesterol lowering medication.
- 125 million Lipid panels are performed annually in the United States.
- More than 8 million Americans enter emergency rooms with chest pain each year.
- 20 million cardiac marker panels are performed each year.