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Advanced Cholesterol Sub-fraction Test Cleared by the FDA

November 9, 2001

Redondo Beach, CA – November 9, 2001 – The Food & Drug Administration (FDA) has just recently cleared Quantimetrix Corporation’s new Lipoprint System, the only test that measures how much cholesterol is in each LDL (bad) sub-fraction. This new test gives physicians more specific data about a patients LDL sub-fractions (bad cholesterol).

Researchers have shown small dense LDL sub-fractions to be the ‘badest” of the bad cholesterol. In the case of a patient’s lipid sub-fractions, size is extremely important. As the LDL sub-fractions (particles) become smaller and denser, they can more easily penetrate the coronary artery wall and contribute to a narrowing of the blood vessel.

The Lipoprint System classifies patients into two distinctive profiles. Pattern “A,” which classifies patients with larger buoyant LDL, and pattern “B,” patients with smaller denser LDL. Unlike prior sub-fraction tests, the Lipoprint System measures the specific amount of cholesterol present in each LDL sub-fraction.

The new Lipoprint test allows physicians to see if a patient’s LDL sub-fractions undergo any change in size from targeted drug therapy. As a patients LDL sub-fractions become smaller and denser, they are more prone to building arterial plaque blocking coronary blood vessels. Some cholesterol lowering drugs may lower total cholesterol but also shift the patients LDL sub-fraction profile to the larger less dense sub-fractions that have been shown by research to be a lower cardiac risk. Other cardiac drugs have shown that they actually make small dense sub-fractions smaller and therefore more dangerous.

Cardiac disease is the number one killer in the United States of both men and women, far exceeding cancer and other health risks. The medical cost estimates for treating cardiovascular disease in the US is over $150 billion yearly. New diagnostic tools like sub-fraction testing may help physicians reduce some of these costs.

Prior to the Lipoprintä System, LDL sub-fraction testing usually took several weeks for the physician to receive test results and the costs were prohibitive. For these reasons, few HMO’s or private insurance companies encouraged their members or their physicians to utilize this type of cholesterol test. Another draw back with prior sub-fraction tests was that the prior diagnostic methods were research based and results varied widely between different methods.

The new Lipoprint sub-fraction test can be completed in less than two hours for approximately 1/20 of the cost of previous testing methods. In addition, the Lipoprint test can be easily set up in any laboratory setting, allowing physicians in any location to compare their LDL sub-fraction test results. Fortunately for patients, the test requires only a tiny amount of blood to give a complete measurement of 12 different LDL sub-fractions and 19 different lipid variables.

If the Quantimetrix Lipoprint test proves to be a better diagnostic for patients with lipid disorders, it may allow patients, physicians, HMO’s and the government to more specifically decide what therapy is best for each patient. At the same time, no one can explain the discrepancy of why 50 percent of the heart attack patients met all the government guidelines as having healthy cholesterol. The Lipoprint System can indicate which patients may have “normal cholesterol levels” but still have abnormal LDL sub-fraction profiles.

Besides receiving FDA clearance, Mayo Medical Laboratories adopted this testing system and currently many other clinics and labs across the country are using the system. In addition, this cholesterol testing system has been published in prestigious industry journals such as Clinical Chemistry and the AACC Journal.

Founded in 1974, Quantimetrix Corporation is a developer and manufacturers of clinical diagnostic products and lipoprotein research/testing. Quantimetrix corporate headquarters is located at 2005 Manhattan Beach Blvd., Redondo Beach, CA 90278; phone: 800-624-8380. Additional information is available at www.4qc.com.