Subject: Calypte Is Seeking To Get Urine Test For HIV Approved 
Date: Published: 9/16/92 (52 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Health:
    Calypte Is Seeking
    To Get Urine Test
    For HIV Approved
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    BERKELEY, Calif.  -- Calypte Biomedical Corp. said it filed a
 product license application with the Food and Drug Administration
 for a urine test that screens for the AIDS virus.
    Currently blood tests are used to screen for antibodies to the
 human immunodeficiency virus, which causes AIDS.  Calypte's Chairman
 Howard Urnovitz said the experimental urine test offers a safe and
 cheap alternative that eliminates needles and infectious waste.
    Dr. Urnovitz said HIV testing makes up a third of the $1.5
 billion global diagnostic testing market.  The HIV blood-test market
 is divided among 13 major diagnostics firms, led by Chicago-based
 Abbott Laboratories.
    "The urine test will be a supplement.  Blood testing does a good
 job," Dr. Urnovitz said.  "We don't see it replacing blood tests in
 blood bank screening."  But he said in certain settings where drawing
 blood with needles is currently impractical or dangerous, it could
 carve out a niche market of some $20 million to $35 million a year
 within the next two to three years.
    That niche would include screening by public health workers who
 track HIV, and testing by insurance companies and the military, as
 well as "the personal health market," of people who go to their
 doctor to be tested.
    Calypte said it is submitting data on testing of 530 people to
 the FDA that supports its claim that the urine test is comparable to
 the blood test in sensitivity and specificity for HIV.  "No test is
 100% accurate," Dr. Urnovitz concedes, but adds that his test
 suffers no more problems with false positive or negative readings
 than current blood tests.
    Safety could prove a potent marketing tool for urine testing.
 Like blood, urine contains antibodies that signal a person's
 infection.  Unlike blood, urine doesn't contain infectious virus,
 making it less dangerous to handle.
    But economy may be the major selling point.  Dr. Urnovitz said
 that because blood testing requires the services of a trained
 blood-drawing technician, insurance companies pay as much as $100
 for the current blood test.  "We could easily cut that in half," he
 said.

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