HIV Test Kit Maker Sues for State OK to Sell : Marketing: The Costa Mesa manufacturer of the in-home device says regulators are unfairly withholding approval.
An Orange County manufacturer of an in-home HIV test kit has sued the state Department of Health Services, complaining that the agency is unfairly withholding approval for it to sell its product.
The suit, filed Friday by Health Test Inc. in Orange County Superior Court, asks the court to order the agency to perform its duty--in this case, give the company permission to sell its $24.05 blood test that it says can detect the human immunodeficiency virus in the bloodstream. HIV is the virus that causes acquired immune deficiency syndrome, or AIDS.
Stephen J. Coonan, president of Health Test, which was founded in 1991 to tap into the potentially lucrative HIV testing market, said that he has been stonewalled for almost two years and that the lawsuit was the only solution, he said.
Coonan said that the Costa Mesa company has amended its application eight times in the past 21 months, but has still not received an approval or an outright rejection.
“This has been an incredible journey through the approval process,” he said.
A state health official in Sacramento said Monday that he has not seen the suit, but argued that Coonan’s application was so riddled with problems that they have wrestled 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 Department of Health Services. “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 test kit over the counter as a way to ensure the privacy of those wishing to test for the virus without having to visit a clinic.
The test kit consists of a simple pen-like device used to draw blood and a blotter to collect it. The blotter would then be mailed to Health Test for evaluation. As planned, results of the test would be ready within a week.
Health Test said it applied for marketing approval with the state rather than the U.S. Food and Drug Administration because it thought it would take less time. With only state approval, however, the kit could not be sold outside California.
The company said it has already invested more than $300,000 setting up a laboratory to conduct the tests and establishing a hot line for those who test positive for HIV, 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 those who test positive would not have proper access to counseling.
Dr. Lauri Thrupp, a chief of infection control at UC Irvine School of Medicine, said that lack of counseling is a major concern for those working to fight AIDS and to help those who contract the virus.
He also said that the trauma associated with testing positive for HIV is so great that the threat of false readings calls into question the value of taking an unsupervised home test.
“There are a lot of issues that have to be solved,” Thrupp said. “I am not sure (anyone) has come any nearer to solving these. (Home HIV testing) will continue to be a great debate for some time.”
But Coonan said that his test kit is effective and would be monitored by a state-approved laboratory.
In court documents, the company asks the court to force the state agency to reach a decision immediately. And if the state rejects the application, Health Test asks that the state provide it “with a specific list of guidelines and requirements for the approval of the distribution of kits.”
Barquest with the state agency said that although there have been concerns about the HIV testing product as well as serious questions about the scientific validity of the application, he added that Coonan “is much closer to approval than he was.
“Our review has been as timely as possible,” Barquest said, “given the condition of the application. We can’t put all of our staff on this.”