Judge Orders Showdown on HIV Home-Test Kit : Health: State must OK sales or explain why Costa Mesa firm has been waiting 2 years for license.

An Orange County Superior Court judge Tuesday ordered state health officials to quickly approve sales of a controversial home health test for HIV, the virus that causes AIDS, or provide a detailed list of reasons why not.

Stephan J. Coonan, president of Health Test Inc. of Costa Mesa, said that the court order by Superior Court Judge Leonard Goldstein requires officials of the state Department of Health Services to appear in court Dec. 3.

“I feel victorious,” Coonan said. “I am very thankful that the judge has recognized the fact that the state has been dragging its feet.”

The court order was made after Coonan filed suit Sept. 27 in an effort to get state health officials to make a decision on his company’s proposed human immunodeficiency virus test kit.

Coonan said his company has been stonewalled for almost two years in its effort to get state approval to market the test in California. Health Test would also have to receive U.S. Food and Drug Administration approval if it wants to eventually market the product in other states.

The test kit would allow users to test themselves for HIV at home. The test kit consists of a simple pen-like device used to draw blood and a blotter to collect it.

The blotters would then be sent to Health Test’s laboratories, where laboratory technicians would evaluate the blood sample and report results either my mail or phone.

Coonan said there is a large market for such a test kit, which would be the first one of its kind in the nation, because of the strong desire for privacy in relation to the AIDS virus.

James Barquest, chief of the medical devices unit of the state Department of Health Services, said Tuesday that he had not heard about the court order. Goldie Eng, the health services attorney assigned to the Health Test case, was not available for comment Tuesday.

David Anast, publisher of the Costa Mesa-based Biomedical Market Newsletter, said he has been watching this case closely and applauded the decision.

“The state crossed the line a long time ago in treating this company fairly,” Anast said. “It’s critical that services like this be made available to the public, if they meet medical requirements.”

Coonan has long argued that his test kit is effective, and should be approved. But if the test is deemed to be unreliable, he said, the state should have told him long ago. Instead, Coonan said, he has been forced to scale the company back to a handful of employees, waiting months for word on whether the test kit could be marketed.

“What this (court order) says is, ‘Either you give them the license or you tell them exactly what it is they are doing wrong,’ ” Coonan said. “Now we’ll get a fair review.”