Big news not picked up by Dow Jones for some reason.
This study highlights the ability of Calypte's urine based test to pick up the presence of HIV where current blood tests cannot.
(PR Wires) DJ: Calypte Biomedical Scientist Presents Data On HIV Test D
DJ: Calypte Biomedical Scientist Presents Data On HIV Test Discordancies
SAN JOSE, Calif.--(BUSINESS WIRE)--April 23, 1999--Presenting at the Oak
Ridge Conference of the American Association for Clinical Chemistry (AACC),
Dr. Howard Urnovitz, chief scientific officer of Calypte Biomedical
Corporation (NASDAQ: CALY), explained results of a significant clinical
study of 826 individuals at high risk for HIV, whose blood and urine were
tested for antibodies to HIV-1. The study, which was conducted by Calypte in
conjunction with Independent Reference Laboratory, produced 10 individuals
with discordant results -- meaning their blood and urine results did not
agree. The 31st Annual Oak Ridge conference is Friday and Saturday, April 23
and 24, at The Fairmont Hotel, in San Jose.
In six of these individuals tested, antibodies to HIV-1 could be detected in
urine but not in the matched blood sample. These six subjects have been
described as urine positive/serum negative, or UPSN. In the remaining four
individuals, antibodies could be detected in serum but not in urine.
Follow-up testing is planned for all 10 of these individuals, during which
time an independent lab will test them to determine if the HIV-1 virus
itself, and not just antibodies to HIV-1, can be detected.
Dr. Urnovitz presented this data in the plenary session entitled: "Beyond
Blood: The Use of Alternative Body Fluids and Detection Methodologies."
During his presentation, Dr. Urnovitz explained that two of the six UPSN
subjects in this study had a urine reactive panel with antibodies to all the
components of HIV-1, strongly suggesting HIV-1 infection. The six UPSN
individuals identified brings the total to 18 persons in four different
clinical studies where the urine test showed antibody reactivity to the
virus while the blood tests did not. These various studies, conducted over
the past six years, continue to suggest that in certain individuals the
immune system will produce antibodies to HIV that are detectable in certain
bodily fluids but not in others.
A notable example of the variation in immune response was revealed in a
recent study published by the journal AIDS (January 1999). This study
reported on eight individuals with HIV-1 infection and AIDS who tested
positive by nucleic acid testing for HIV-1 virus. Three of the eight
individuals were persistently non-reactive by all licensed blood antibody
screening tests. The remaining five were weakly reactive by some licensed
tests, but non-reactive by other tests. All subjects were HIV-1 negative
using blood-based FDA-licensed confirmation tests. "This study, together
with the data we have seen in other studies, supports our concern that the
immune response to the HIV-1 virus is variable and that combination testing
of multiple bodily fluids may yield a higher sensitivity protocol for
detecting exposure to HIV-1," Urnovitz stated.
"To date, we have relied primarily on testing for antibodies to HIV in blood
to screen for HIV exposure," Dr. Urnovitz continued. "Clinical studies
conducted during the past five years have indicated that the highest levels
of sensitivity may be obtainable by testing for antibodies in multiple body
fluids as well as testing for the virus itself with the new nucleic acid
tests such as PCR."
This year's Oak Ridge Conference is titled: "On the Road to Non-invasive
Testing, the New Millennium of Minimally Invasive and Non-invasive
Technologies in Clinical Settings." The internationally recognized
conference is designed to help scientific leaders learn how emerging
technologies will revolutionize testing in the clinical laboratory of the
next millennium.
Calypte Biomedical Corporation is an Alameda, California-based health care
company dedicated to the development and commercialization of urine-based
diagnostic products and services for HIV-1, sexually transmitted diseases
and other chronic illnesses. Calypte manufactures the only two FDA-licensed
HIV-1 antibody tests that can be used on urine samples. These tests include
the screening EIA and supplemental Western blot tests.
Urine testing is non-invasive, less costly, does not require sample storage
or a trained health care worker for sample collection, and is safer because
there are no risks of accidental needle sticks. Also, while urine contains
antibodies to HIV, it does not contain the actual virus. The availability of
both a urine screening test and a urine supplemental test makes it possible
to perform a full diagnostic HIV-1 antibody algorithm without ever drawing
blood.
Statements in this press release that are not historical facts are
forward-looking statements, including statements regarding market adoption
of the HIV-1 urine testing system. Actual results may differ materially from
the above forward-looking statements due to a number of important factors,
and will depend upon the Company's ability, directly or through third
parties, to successfully manufacture and market the HIV-1 urine testing
system. Factors which may impact the Company's success are more fully
discussed in the company's most recent quarterly report on forms 10-Q and
10-K.
CONTACT: Calypte Biomedical
Bill Boeger or John DiPietro, 510/749-5100
or
Healy Communications
Jason Sherman, 312/440-3900
17:32 EDT APRIL 23, 1999
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