The manufacturer of a home AIDS test kit has sued the state Department of Health Services, complaining that the agency is unfairly withholding approval for it to sell the product.
Stephen J. Coonan, president of Health Test Inc., which was founded in 1991 to tap the potentially lucrative AIDS testing market, said he has been stonewalled almost two years and that the suit, filed Friday in Orange County Superior Court, was the only recourse.
Coonan said the Costa Mesa company has amended its application to the agency eight times in 21 months but has received neither approval nor outright rejection. “This has been an incredible journey through the approval process,” he said.
A state health official in Sacramento said Monday that he had not seen the suit, but he said Coonan’s application was so riddled with problems that officials wrestled with it for months, trying to get it in order.
“We feel we have given this a reasonable effort,” said James Barquest, chief of the medical devices unit of the state agency. “Mr. Coonan has probably gotten more personal attention with regard to our assistance than anyone I am aware of.”
The company wants to sell its HIV diagnostic kit over the counter, as a way of ensuring privacy for people who wish to test themselves for the virus without having to visit a clinic.
The kit consists of a simple, pen-like device used to draw blood and a blotter for collecting the sample, which would be mailed to Health Test for evaluation. As planned, results would be available within a week.
Health Test said it applied for marketing approval from the state, rather than the Food and Drug Administration, because it thought that would take less time. With only state approval, however, the kit could not be sold elsewhere.
The company said it has already invested more than $300,000 setting up a laboratory to conduct the tests and establishing a phone line for the use of those whose tests are positive, Coonan said.
That idea has drawn fire from some in the medical community who are concerned that the home test kit may not be as accurate as claimed and that people whose results are positive would not have proper access to counseling.
Dr. Lauri Thrupp, chief of infection control at UC Irvine School of Medicine, said lack of counseling is a major concern of those working to fight AIDS as well as patients.