FDA approves first home collection HIV test.

SUNNYVALE, Calif.--(BUSINESS WIRE)--May 14, 1996--The U.S. Food and Drug Administration has approved a home test system for HIV and has cleared U.S. manufacturer Johnson & Johnson to enter the over-the-counter market with the test, it was announced Tuesday.

In February 1995, ChemTrak (NASDAQ:CMTR) filed its own premarket approval application (PMA) for its home access HIV test with the FDA and continues to look forward to eventual FDA approval, the company said.

"PMA submission is a major step toward the commercialization of this important home diagnostic test in the U.S.," said Dr. Prithipal Singh, Ph.D., chairman and chief executive officer of ChemTrak.

"We look forward to the opportunity to expand our own product line to include confidential home access HIV testing -- and we congratulate Johnson & Johnson for winning FDA approval."

According to the Centers for Disease Control (CDC), approximately 33 million HIV tests are performed each year in the United States. About 18% of U.S. adults who have been tested had risk behaviors for HIV infection.

Of the approximately 1 million Americans living with HIV, only 30% to 60% have been tested, and about one-half of those who test positive are too late, when treatment is less successful.

In an FDA announcement concerning the approval of the Johnson & Johnson product, Donna E. Shalala, secretary of health and human services, said: "Too many Americans do not know their HIV status. Knowledge is power, and power leads to prevention. The availability of a home test should empower more people to learn their HIV status and protect themselves and their loved ones."

The FDA announcement also said: "Technological advances in the accuracy of HIV antibody testing, the availability of treatments for people who are infected but do not yet have symptoms, and the public health benefits that would accrue from more people being aware of their HIV status all contributed to the agency's decision to approve the kit for home use.

"The decision is consistent with advice that FDA received at a June 1994 meeting of FDA's Blood Products Advisory Committee. At that meeting, the committee concluded that the potential benefits of over-the-counter home specimen collection kits outweighed the potential risks."

The ChemTrak HIV test calls for a user to prick a finger with a lancet, then allow three drops of blood to be absorbed by a special paper with a unique identification number and mail the specimen in a postage pre-paid mailer to ChemTrak.

The company tests the blood for HIV using standard laboratory screening and confirmatory testing methodology. About a week after mailing the specimen, the user calls the company's counseling center toll-free number and provides the test identification number. The user then receives professional counseling, a test result, and if the result is positive, referral to local care.

Unlike a conventional home test, such as a pregnancy or total cholesterol self-test, the ChemTrak home access HIV test includes testing as well as counseling and referral to local care. The test is positioned as a confidential, anonymous alternative to current HIV testing practices and is expected to be regularly used for relationship wellness testing.

ChemTrak is a full-service personal diagnostics company that develops and manufactures reliable and easy-to-use home testing systems. ChemTrak test kits are designed to screen and diagnose health conditions with accuracy comparable to physician office and laboratory instrumented tests.

The company markets its products to over-the-counter and professional markets worldwide, directly and through strategic alliances with established health care and consumer products companies.

CONTACT: ChemTrak Inc., Sunnyvale

Alene A. Holzman, 408/773-8156

or

Freeman/McCue Public Relations

Timothy L. Dolan, 714/557-3663