Wall Street Journal
September 22, 2000
By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL
Testing for Serious Conditions Can Now Be Done at Home
IS THE BATHROOM the diagnostic laboratory of the future?
Today patients can do home screenings for colon cancer and self-test for high-cholesterol, urinary-tract infections, osteoporosis risk and low libido. Home tests that can screen for prostate cancer, check for the onset of menopause, allergies, thyroid and liver problems are in the works or already available on the Internet. Even QVC, the popular home-shopping channel, is considering selling home health tests.
Home pregnancy and drug tests have been available for years, of course, but the products being offered today are increasingly sophisticated and are intended to screen for serious medical conditions.
Some of the tests use urine or stool samples and results are obtained in minutes at home. Others include lancets, swabs and vials to collect blood, which is then sent in a postage-paid mailer to a laboratory. Prices for the home tests range from $10 for a simple diabetes check to $70 to test for Hepatitis C.
Many of these tests have even gained credibility with the long-skeptical medical community. The downside is that insurance companies don’t pay for home-test costs, and most doctors will order their own tests for patients regardless of a home-test result.
HOME TESTING HAS its limits. Still, "it’s a wonderful opportunity to diagnose disease early and save money," says Edward A. Taub, a Dana Point, Calif., physician and author of several popular "wellness" books who has been researching home-test kits for QVC.
Some of the tests being sold over the Internet aren’t yet FDA approved for retail sale. However, a loophole allows companies to sell the tests directly to consumers. The test makers get around the FDA restrictions by having physicians’ order the tests for consumers who buy them.
The prostate screening test measures prostate specific antigen or PSA levels in blood collected at home and mailed to a lab. Elevated PSA levels could indicate prostate cancer, though not always. BioSafe Laboratories of Chicago is seeking FDA approval to market the test, which currently is available only through the Internet or by telephone. In January, BioSafe will begin offering home blood tests for cholesterol, thyroid conditions and allergies, says chief executive David Fleisner.
Although home tests for colon cancer have been available for a few years, they haven’t caught on with consumers because they require a smear of fecal matter. Two brands, ColoCare, made by Helena Laboratories of Beaumont, Texas, and EZ Detect, from Biomerica of Newport Beach, Calif., now offer a test strip that is dropped into the toilet as a way to detect blood in the stool. But chemicals in the water, hemorrhoids or even having eaten a rare steak for dinner can register a false positive—and the test may not detect hidden blood. To improve reliability, the kits include pads for three tests, as well as ways to test for existing chemicals in the toilet water.
Not all of the tests are accepted as accurate or even meaningful screening methods for disease. Over-the-counter tests for osteoporosis, for instance, measure levels of bone alkaline phosphatase, or BAP, in the urine or blood. Although BAP is one marker often studied in bone loss, the presence of BAP alone is not widely accepted as a good indicator of osteoporosis risk.
THE FDA HASN’T approved any tests for home breast-cancer screening, although a test that measures an antigen known as CA15-3 is available over the Internet. The FDA has approved the antigen test for professional use to screen for the recurrence of breast cancer in women who have already been treated for the disease, but the test hasn’t yet been accepted as a reliable screening method for the general population.
The BodyBalance AntiOxidantCheck, made by Great Smokies Diagnostic Laboratory in Asheville, N.C., measures lipid peroxides to determine free-radical activity believed to be linked to heart disease and cancer. But unlike cholesterol, which is easily monitored, scientists don’t have guidelines for determining healthy or unhealthy level of lipid peroxidation, says Jeffrey Blumberg , chief of antioxidants research laboratory at Tufts University.
Regardless of the scientific validity of the tests, many consumers want a "snapshot" of what’s going on in their bodies, says Frank Taylor, Great Smokies chief executive.
Ken Adams, president of Home-Healthtesting.com, said sales on his site are growing by more than 30% each year. The most popular tests are cholesterol tests and tests for a variety of drugs, including marijuana, tobacco and cocaine, typically used by parents to check up on their kids.
One of the biggest problems with home testing is that consumers often don’t follow the directions, says John C. Rogers, professor of family and community medicine at the Baylor College of Medicine in Houston.
As a result, many physicians worry that incorrect use of the tests could result in false negatives, prompting patients to skip a doctor’s visit. Another concern is whether patients can understand the results or deal on their own with the emotional stress of a poor result. Doctors say the best use of a home test is in-between regular checkups, and patients can protect themselves from unreliable tests by discussing test results with their physician.
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