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CALIFORNIA DEPT. OF HEALTH SERVICES SUED BY AIDS TESTING LABORATORY

Clinical Laboratory Licensed By DHS to Perform New HIV Test Procedure,
 Then Suddenly Told They're Not Allowed to Operate
 COSTA MESA, Calif., Sept 27 /PRNewswire/ -- Health Test Inc. (HTI) has sued California Department of Health under Writ of Mandate to force it to make a final approval of Health Test's new HIV self-collection device, called HIV Home Check. Health Test alleges that, over the past two years, it has made over eight separate formal and informal applications to modify the product according to DHS guidelines. Upon each resubmittal, however, DHS guidelines were changed to negate the previous ones.
 HTI also alleged in the action filed at the Orange County Superior Court that an official of the DHS, Stuart A. Richardson, directed employees to intentionally derail approval of HTI's application. The suit also mentions that Richardson had received a 30-day suspension for acting beyond the scope of his authority as chief of the Food and Drug Branch of the DHS.
 Health Test Clinical Laboratory was licensed by DHS Laboratory Field Services to perform HIV testing in May. Suddenly, in June, the company was told the test was illegal by DHS Food and Drug, a sister agency of Laboratory Field Services. "In essence, Health Test now holds a license to perform an illegal test," says Stephen J. Coonan, Health Test president.
 According to Coonan, the procedure is used non-commercially on over 1 million Americans per year as a prerequisite for obtaining life insurance coverage, and is the mainstay testing protocol of the Centers for Disease Control neonatal HIV testing program.
 When licensed, Health Test became the first clinical laboratory in the country licensed to perform blood spot testing on a strictly commercial basis.
 The process consists of performing simple finger stick to collect blood on a filter paper and returning the specimen to Health Test. The specimens are screened using the popular ELISA method and confirmed with Western Blot. Results, including confirmation of positive results, are obtained in approximately four days.
 Health Test Inc. is located at 380 Clinton St., Costa Mesa, CA 92626. Contact Steve Coonan at 800-564-0003, or 714-755-6990 (outside California) for further details.
 -0- 9/27/93
 /CONTACT: Steve Coonan, 714-755-6990 (outside California), or 800-564-0003/
 (HTI)


CO: Health Test Inc.; California Department of Health ST: California IN: HEA SU:

NY-MF -- LA007 -- 5729 09/27/93 03:01 EDT
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Publication:PR Newswire
Date:Sep 27, 1993
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