Some insurance companies are using a saliva-based AIDS test to screen potential customers even though the procedure has yet to be approved by federal regulators.
Three or four companies last month started using a saliva test made by Epitope Inc. of Beaverton, Ore., said Gregg Sadler of Home Office Reference Laboratory Inc., a Kansas City-area laboratory marketing the test.The lab is selling the test to about 800 insurance companies, although it is too soon to know how many will use it, Sadler said.
The test has yet to be approved by the Food and Drug Administration.
An FDA official in Washington, who spoke on the condition he not be identified, said the agency was unaware the insurance companies were using the test before an inquiry from United Press International.
He said FDA officials planned to meet with Epitope representatives. "We don't know a lot about it," he said of the insurance companies' use.
Officials at Home Office, Epitope and an insurance company all said FDA approval is not needed as long as the test is used for screening potential policy-holders, rather than diagnosing a disease.
The FDA official said the agency is uncertain about that claim.
The FDA has approved experimental use of the test at five hospitals around the country to test its effectiveness, and OraSure appears as reliable as blood tests, said Andy Goldstein, Epitope's vice president for product development. However, the test is not available to doctors and hospitals for non-experimental use.