FDA Approves Home Test Kit for Blood Cholesterol

WASHINGTON —  The Food and Drug Administration Tuesday approved the first home test kit to measure blood cholesterol, a major risk factor associated with heart disease.

Heart disease is the leading killer of Americans.

Federal health officials said that 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 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 multicenter 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, according to Alene Holzman, of ChemTrak. She said that price is “comparable to what a lab charges.”

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

Tuesday’s action adds the cholesterol test to a range of other home exams that include tests for ovulation, pregnancy, blood glucose, hidden fecal blood, blood pressure and urinary tract infections. While it is not clear what impact the cholesterol test will have, many health care experts believe that home testing is the wave of the future.

“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. “I think that all factors, including cost, consumer demand, efficiency and speed--meaning not having to wait three days for test results--point in the direction of the laboratory coming into the living room.”

But he and others cautioned that there also are 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 Assn. “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.”

Officials at the American Heart Assn. agreed.

“If the FDA determines that a home cholesterol testing device meets its standards for accuracy and reliability, (we) believe the device would be a useful tool to patients whose cholesterol is being monitored by a physician,” the AHA said in a statement. “These home devices would empower patients to work in partnership with their physicians . . . (to) help reduce the risk of heart disease and stroke.”

ChemTrak’s test is based on technology the company developed and 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, 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 are available in 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 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, nevertheless, is generally an accurate predictor of whether further medical action 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. Individuals whose total cholesterol is above 200 are advised to see physicians.

The National Cholesterol Education Program of the National Institutes of Health recommends that individuals with readings of 200 or below have their cholesterol checked every five years and that those with higher readings follow the recommendations of their doctors for frequency of screening.

ChemTrak said that it hopes to devise a test in the future that can distinguish between HDL and LDL cholesterol.

The test kit will contain detailed instructions for its proper use and a discussion of the test’s limits. It also will include information on cholesterol, heart disease, diet and exercise and provide a toll-free number for consumers to call for additional information. The number is 1-800-927-7776.

“Accuracy is crucial,” said FDA Commissioner David A. Kessler. “It is also important, as the study showed, that participants were able to read and understand the instructions and perform the test without assistance.”

The agency warned, however, that the test should not be used by hemophiliacs or individuals who are taking blood-thinning medications, since the finger prick could result in excessive bleeding. Those individuals should have their cholesterol screening performed by their physicians, the FDA said.