The Food & Drug Administration (FDA) has cleared Quantimetrix Corporation's new Lipoprint(TM) System, the only test that measures how much cholesterol is in each LDL (bad) sub-fraction. The FDA approval of this new test, which gives physicians more specific data about a patient's LDL sub-fractions (bad cholesterol), came just as recommendations for more cholesterol lowering drug therapy was announced by the NCEP (National Cholesterol Educational Program).

Researchers have shown small dense LDL sub-fractions to be the `baddest" 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 test allows physicians to see if a patient's LDL sub-fractions undergo any change in size from targeted drug therapy. As a patient's 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 patient's 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 No. 1 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 U.S. is over $150 billion yearly. New diagnostic tools like sub-fraction testing may help physicians reduce some of these costs.

LDL sub-fraction testing can take several weeks for the physician to receive test results and the costs were considered prohibitive. For these reasons, few HMOs or private insurance companies encouraged their members or their physicians to utilize this type of cholesterol test. Another drawback with prior sub-fraction tests was that the prior diagnostic methods were research based and results varied widely between different methods.

The new 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, HMOs 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.