Cholesterol home test is approved Kit expected to cost $10 to $15


WASHINGTON -- The Food and Drug Administration approved yesterday the first home test kit to measure cholesterol, a major risk factor associated with heart disease, the leading killer of Americans.

U.S. health officials said they hope the widespread availability of the new test kit, which is expected to be in drug stores before the end of the year, will encourage more consumers to determine their cholesterol levels and seek medical attention if the readings are too high.

Promoting such awareness by consumers is consistent with the Clinton administration's philosophy of emphasizing preventive health measures to detect potentially serious medical conditions before they become life-threatening and before they develop into problems that are far more expensive to treat.

"This test can help give consumers greater opportunity to monitor their health and take steps to prevent disease," Health and Human Services Secretary Donna E. Shalala said in a statement. "Making it more convenient to check on cholesterol can help ensure that people are aware of the level so they can see a doctor before serious problems develop."

The FDA's decision to allow the test to be sold over the counter was based on the results of a multi-center clinical trial involving nearly 500 adults. The research showed the test to be as accurate as cholesterol tests used by physicians and medical laboratories.

An estimated 17.6 million Americans have heart disease, which claims about 734,000 lives in the United States every year. Until now, only medical professionals were permitted to perform cholesterol screenings.

High cholesterol is one of several important risk factors associated with heart disease. Others include high blood pressure, smoking, obesity, and a family history of heart disease before age 55.

The Accumeter Cholesterol Self-Test was developed by ChemTrak Inc. of Sunnyvale, Calif., and will be marketed by American Home Products of New York. It is expected to cost about $10 to $15, "comparable to what a lab charges," according to Alene Holzman of ChemTrak.

But consumers will be spared the expenses that are associated with an office visit to a physician.

"I honestly believe that home testing is going to revolutionize diagnostic medicine," said Arthur Caplan, director of the University of Minnesota center for biomedical ethics.

But he and others cautioned that there were also dangers associated with home testing, such as accuracy and interpretation of test results.

"We aren't opposed to home tests, especially the [blood glucose] kind associated with diabetes monitoring, but physicians feel strongly that they treat patients -- they don't treat test results," said James H. Stacey, a spokesman for the American Medical Association. "It's very important for the doctor to get to know the patient. A test should only be used as an auxiliary in diagnostic procedures."

ChemTrak's test is based on technology the company developed. It is the first to measure quantity of cholesterol without the use of instruments.

The test comes with a sterile disposable device that is used to prick the finger to obtain several drops of blood, Ms. Holzman said. "You push a button, and it is practically painless," she said.

The blood is put into another unit, a special well, that contains a test strip that resembles a thermometer, and the results take about 15 minutes, she said. The unit contains a test strip that changes color. When the time period for the test ends, the consumer compares the color on the strip with an accompanying conversion chart to obtain the cholesterol reading.

The test measures total cholesterol and does not separate the HDL, or "good" cholesterol from the LDL, or "bad." But a total reading is generally an accurate predictor of whether further medical attention is necessary.

A total cholesterol level of 240 or above is considered high. But even levels below that -- 200 to 239, which is considered "borderline high" -- may increase the risk of heart disease.

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