FDA CLEARANCE
rine-Based System Offers Highly Accurate, Low-Cost,
Low-Risk Alternative to Blood Testing
BERKELEY, Calif., June 1 /PRNewswire/ -- Calypte Biomedical
Corporation (Nasdaq: CALY) announced today that the U.S. Food and Drug
Administration has licensed the urine HIV-1 Western Blot test that
confirms the presence of antibodies to Human Immunodeficiency Virus
Type 1 (HIV-1) in urine samples. The new test is used on samples that
are repeatedly reactive in the Calypte HIV-1 urine antibody screening
test. The new test completes the only available urine-based HIV test
system. Clinical studies have shown this urine diagnostic test system
to be a highly accurate alternative to blood testing.
For both health care professionals and patients, urine testing offers important advantages
compared to existing blood-based HIV tests. Those advantages include greater ease-of-use
for health care workers, strong appeal to consumers and the lower cost of urine collection.
According to the National Institutes of Health Fact Sheet on HIV Infection and AIDS, there
is no evidence that HIV is spread through urine, thereby significantly reducing risk of
infection from collecting and handling specimens. Urine testing eliminates accidental
needle sticks and other exposure-related dangers, thus protecting both health care workers
and patients.
In addition to the benefits the test offers to the health care system, the urine test system is
expected to become an attractive alternative for domestic and international health agencies
that do not have access to the funds, personnel or facilities required for blood collection and
testing. It is also expected to appeal to many Americans who have avoided being tested in
the past because they dislike having their blood drawn. In fact, a recent survey of
approximately 1,000 Americans conducted by Market Facts, Inc. showed that one of every
two respondents would prefer a urine HIV test over a blood test. Of those respondents, 80
percent cited a fear of needles as their reason for preferring the urine test. There were
approximately 60 million HIV tests performed in the United States in 1997.
To determine the specificity of the urine Western Blot, clinical trials were conducted on a
low risk population. Blood serum and urine samples were tested and results compared. The
results showed that the specificity for this population was 100 percent (515 out of 515).
To determine the sensitivity of the urine Western Blot, clinical trials were conducted on
persons known to be HIV-1 antibody positive by blood tests. Serum and urine samples
were tested and results compared. The results showed that the sensitivity of the urine
Western Blot was 99.7 percent (746 out of 748). The two samples that were urine Western
Blot negative were from seropositive individuals that had AIDS and were on anti-retroviral
therapy.
In a second study of 391 high-risk individuals of unknown HIV status, 17 were positive by
both urine and serum tests (100 percent). However, in three samples the urine Western
Blot was positive while the paired serum sample was negative or indeterminate. Calypte
scientists believe that these discordant samples in the high-risk group may reflect the
unique nature of HIV-1 infection, and point to an important new research direction. An
article published in the November 1997 issue of Nature Medicine reported on the clinical
trial data for the Calypte Biomedical HIV-1 urine EIA (the urine screening test) which tested
over 11,000 paired urine and serum specimens in low-risk, high-risk and known HIV-1
seropositive populations. It was revealed that a combination of urine- and blood-based tests
detected HIV-1 antibodies with greater sensitivity than can be achieved by either test alone.
Dr. Howard Urnovitz, Calypte's Founder and Chief Science Officer, the leading author of the
paper, said: "Finding the HIV-1 antibody in only one part of the body, as we did by testing
both urine and blood, suggested to us that HIV infection may be compartmentalized." This
speculation was recently confirmed by a multi-center study led by Dr. Ann A. Kiessling,
Beth Israel Deaconess Medical Center, Harvard Medical School. "The concept of
compartmentalization is important to HIV disease because it emphasizes the need to
understand HIV infection in each and every tissue," said Dr. Kiessling. "Urine-positive,
serum-negative individuals represent an important group of people who may have limited the
virus infection to a few compartments in the body. Understanding the mechanism of
compartmentalization is urgently needed in order to design fully effective antiviral treatment
strategies."
Another leading HIV scientist, Dr. Emilia Sordillo of St. Luke's-Roosevelt Hospital Center in
New York City, participated in the evaluation of the now approved HIV-1 urine test system.
During these evaluations, she identified an individual with 46,600 copies/ml of HIV virus in a
urine-positive, blood- negative individual. Dr. Sordillo said that, "These unexpected findings
suggest the need to test multiple body fluids to help us further define the dynamics of HIV
infection."
In addition, Professor Luc Montagnier, a member of Calypte's Scientific Advisory Board and
the scientist who first isolated HIV, said, "Distinct reservoirs of HIV coexisting in different
tissue compartments could explain the finding that some high-risk individuals have
discordant antibody responses in urine and blood. These results on discordant samples
provide new insights on how the immune system handles HIV infection. We hope this will
assist in the development of new HIV treatments."
The urine Western Blot test has another advantage over blood testing. Western Blots using
blood have a higher frequency of indeterminate results. Indeterminate results on a Western
Blot test format are results in which it cannot be determined if the patient sample is positive
or negative. According to package inserts from two different blood HIV-1 Western Blots
manufacturers, indeterminate results for low-risk individuals range from 11 percent to 37
percent. The urine Western Blot results showed only 0.2 percent (1 out of 515)
indeterminate in a low-risk population. In a clinical study to compare directly the frequency
of indeterminates between blood and urine systems, 109 patients who had serum
indeterminate results were chosen. The urine from these 109 seroindeterminate patients
was then tested on the urine Western Blot. The urine Western Blot test provided a definitive
result of negative in 105 of the 109 seroindeterminate samples. Dr. Toby Gottfried, Calypte's
Director of Research and Development, said, "Because the urine Western Blot provides
such a remarkably low frequency of indeterminate results, this is a clear advantage over
blood testing in a laboratory environment."
Cambridge Biotech Corporation manufactures the new urine-based supplemental test under
license from Calypte. Cambridge was the first manufacturer to receive a license from the
FDA for a blood-based HIV-1 supplemental test more than a decade ago. Like most blood
tests, the urine HIV-1 screening test and the urine HIV-1 supplemental test do not detect
the actual HIV virus, but the antibodies produced by the body after exposure to the virus.
Bill Boeger, President and Chief Executive Officer of Calypte, said: "While we are all
encouraged by the recent drop in AIDS deaths due to new combination therapies, the HIV-1
infection rate has not declined. To facilitate detection, we need a non-invasive, inexpensive
and accurate test for HIV, such as the urine test. Many people who may be at risk for HIV
infection have declined testing in the past because of the pain, cost and inconvenience of
having their blood drawn. We expect that by making urine HIV-1 testing widely available,
many people who have previously declined blood testing will now come forward."
A December 1997 report issued by the World Health Organization and UNAIDS concluded,
"Conservative estimates suggest that 9 out of 10 infected people in the world do not know
their HIV status. At current estimates, that would suggest there are over 27 million people
in the world today who have no idea they are infected."
Commenting on the test system's potential outside the United States, Professor
Montagnier cited the benefits of the urine HIV testing system for developing countries. He
said that the urine test would provide a unique opportunity for sites that do not have the
facilities or personnel to safely and effectively collect and test blood samples. "In my
opinion, the urine HIV testing system is highly reliable and readily accepted by the
patients," Montagnier stated. "Another potential use of this test would be to use it for urine
antibody monitoring, which should allow for better follow up of patients and volunteers in
future clinical trials of treatments and vaccines."
Drs. Ron Gray and Maria Wawer, researchers and professors from the Schools of Public
Health at Johns Hopkins University and Columbia University, respectively, have also used
the urine test in Africa. "We found that the people we were testing were more likely to
provide urine samples than blood samples. Overall, the urine HIV test could detect
additional infections for the simple reason that more people agreed to provide a sample."
Keith Waterbrook, Director of Health Services at the Jeffrey Goodman Special Care Clinic in
Los Angles, hailed the announcement as an important development in the fight against HIV
and AIDS. "We operate the largest gay and lesbian clinic in the country, and every day we
take phone calls from people who want to be tested but don't want to have their blood
drawn. Now that it's possible to reliably test for HIV-1 infection with a simple urine
specimen, we have a new testing option that will be greatly welcomed by many in our
community. The urine HIV-1 test will help clinics like ours establish more outreach
programs too, because you can eliminate the cost and scheduling difficulties that always
arise when you need a trained phlebotomist on site to collect blood."
In the United States, Seradyn, Inc. of Indianapolis will market both the urine HIV-1
screening and supplemental tests. Seradyn sells the screening test under the trade name
Sentinel(TM). "Our sales people are reporting tremendous interest in the Sentinel urine HIV
test both from STD clinics that want to offer a painless testing option to the public, and from
a variety of institutions which have been performing high volumes of blood-based HIV testing
routinely," said Seradyn Vice President of Sales and Marketing Tedd Mishkin. "Many of the
people seen in settings like STD clinics, prisons and drug rehabilitation facilities, for
example, are at high risk for HIV. Not only will the urine HIV test be more acceptable than
blood to many of these people, but the ability to do additional testing such as drug screens
on the same urine sample could really help these institutions control their testing costs."
Mishkin also stated that his company took an informal poll of family physicians attending
the national American Academy of Family Physicians conference in Chicago in September
1997. More than 90 percent of the physicians polled by Seradyn indicated that they felt
urine testing would be better tolerated by their patients than blood testing, and that they
would prescribe the test for their patients when it was available through their labs.
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
systems. Actual results may differ materially from the above forward-looking statements
due to a number of important factors, and will be independent 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.
SOURCE Calypte Biomedical Corporation
06/01/98 /NOTE TO EDITORS: For more
information on how to purchase or evaluate the product, please call
John Innocenti of Seradyn at 800-428-4007 (x2957) or Dick Van Maanen of
Calypte at 510-526-2541./
/CONTACT: David Schulte or Jason Sherman of Healy Communications,
312-440-3900; or Bill Boeger, CEO, or John DiPietro, COO, both of
Calypte Biomedical, 510-526-2541/ |
