FDA probes Md. firm in sale of HIV test kits

Tera Technologies says it was `duped'

Electronic commerce

August 21, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

The U.S. Food and Drug Administration is investigating the sale of unapproved home test kits for HIV over the Internet by a Columbia-based company.

The company owner contends that she was duped by a supplier into believing the kits were cleared for sale.

"I definitely feel like we were blindsided," said Deborah Gordon, president of Tera Technologies Inc., a designer and manager of Internet Web sites.

Gordon said the $50 kits are no longer offered for sale through the HIV/Cybermall Web site that her company operates. The site provides information on resources and services for AIDS patients.

The executive said that as best as her company can determine, only eight orders were placed for the kits. She said her company became suspicious last month about whether a supplier by the name of "Stan" was actually shipping orders. Gordon said she is cooperating with the FDA investigation, but did not know Stan's last name and dealt with him only by phone and e-mail.

Jason Brodsky, an FDA spokesman, confirmed that the Rockville-based regulatory agency is investigating sale of the kits, but declined to comment further. The FDA has advised people who have the kits to destroy them.

At issue is an HIV test a Miami company, Americare Health Scan Inc., is developing. The test, Ana-Sal, uses saliva samples to detect three strains of the human immunodeficiency virus that causes AIDS, Americare says.

The test is not approved for sale in the United States.

Dr. Joseph D'Angelo, founder and president of Americare, said yesterday that his company's lawyer sent Tera Technologies letters to cease using the Ana-Sal name on the Web site and that he never heard of Gordon prior to learning of the FDA investigation. He said his company has cooperated with investigators.

D'Angelo also said he never heard of the man Gordon claims she was dealing with, but said his company has encountered other Web sites offering the Ana-Sal test kit for sale and has ordered them to cease as well.

"We can't control what these people are doing. A lot of these people are like a breath of air. They disappear like that," said D'Angelo, a former facial surgeon.

Only one home-based HIV diagnostic kit is approved for sale in the United States -- the Home Access Express HIV-1 Test System, made by Home Access Corp.

The FDA says that a number of unapproved HIV test kits have been offered over the Internet, and advises consumers that such kits may be unreliable.

In February, Larry Greene, 51, of Los Banos, Calif., was given five years in prison for selling and distributing an unapproved home test kit for HIV over the Internet.

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