Until a few years ago, the only health-care diagnostic device in most home medicine cabinets was the lowly thermometer. For anything more complicated than confirming a fever, most Americans had to consult their doctor.
Thanks to advances in biotechnology, there are now simple at-home tests to detect pregnancy, monitor blood-sugar levels and detect signs of colon cancer--all without seeing a doctor.
And within a year, manufacturers expect to begin producing a second generation of tests that may be able to detect everything from strep throat and certain kinds of cancer to sexually transmitted diseases and allergies.
The tests are being hailed as an important advance for consumers, who have long been concerned about high medical costs. But as the $150-million-a-year home health diagnostic industry prepares to go into high gear, someanalysts wonder whether the Space Age technology can be made inexpensive and reliable enough for widespread consumer use.
Others doubt whether anybody besides a hypochondriac is really interested in routinely playing medical sleuth.
"There's a mass segment of people out there that don't care much about their health unless something goes wrong," said Frederick H. Navarro, research operations manager for Peabody Marketing Group, a health-care market consulting firm in San Francisco. "Generally, people treat their health like they treat their cars."
Only a year ago, the New York-based consulting firm Frost & Sullivan optimistically predicted in an exhaustive 235-page study that self-diagnostic products "are expected to achieve . . . dramatic sales growth." The report cautioned, however, that it was uncertain how soon the fledgling diagnostic test market might take off.
At the time, Personal Diagnostics of Whippany, N.J., boldly predicted that its sales would top $7 million in 1985 for a line of tests for urinary tract infections, diabetic blood glucose imbalance and fertility, as well as tests for strep throat and pregnancy.
But the tests have yet to hit the market, according to Peter Meserol, executive vice president of Personal Diagnostics. And a year after the predictions of prosperity for home diagnostic kits, the market is still largely dominated by a handful of tests for pregnancy and ovulation.
Manufacturers have encountered a host of obstacles.
A skeptical medical community is worried about the effect of the tests on their business. A federal government agency says some tests are undesirable for consumer use. Meanwhile, there are still technical hurdles to overcome in order to make the tests reliable and easy to use. But even if tests are made 95% accurate, makers fear liability problems.
In addition, a major problem may be that Americans aren't as concerned about their health as is widely assumed.
Health Strategies Group, a New York consulting firm, issued a report in 1983 that said that only 34.3 million Americans visited their doctors in 1982 to get a checkup and that just 13 million purchased any medical or surgical supplies for home use.
"As much as 70% of the adult (U.S.) population is relatively complacent about its health," the report said.
Meanwhile, demand for colon cancer tests--actually a test for blood in the stool--has been lackluster, some manufacturers say. And the test is far from perfect. It tends to miss bleeding in about 25% of colon cancers and up to 50% of polyps, experts say.
The nation's 7 million diabetics still rely largely on urine tests to measure glucose in the blood, said Miles Laboratories spokeswoman Deloris Cogan, despite the availability of more accurate home blood tests from Miles and other makers. The newest tests cost about $15 for 25 chemically coated plastic strips. When blood from a pricked finger is applied to a strip, the strip changes color to indicate the level of glucose in the blood. The sole over-the-counter venereal disease test--VD Alert for gonorrhea--can only be used by men and requires users to mail in samples and wait nearly one week for results.
Sales have been sluggish says the maker of the test, Bellbrook, Ohio-based Medical Frontiers.
Mary Guinan, associate director of sexually transmitted disease division of the federal Centers for Disease Control, said the agency is "against home testing for sexually transmitted diseases" and is studying whether other kinds of medical diagnostic tests are also undesirable for consumer use.
"One of the ways we rid ourselves of disease is by treating people appropriately," said Guinan. "If a patient tests him- or herself and the test is negative, that doesn't mean they don't have a disease. The symptoms of gonorrhea and chlamydia are similar. These tests can give a false sense of security."
That prospect worries some companies such as Quidel Inc. in San Diego.