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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 1, 1998
Calypte Biomedical Corporation
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(Exact name of registrant as specified in its charter)
Delaware 000-20985 06-1226727
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(State or other (Commission (I.R.S. Employer
jurisdiction File Number) Identification No.)
of incorporation)
1440 Fourth Street
Berkeley, California 94710
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (510) 526-2541
NOT APPLICABLE
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
Calypte Biomedical Corporation is filing this Current Report on Form 8-K to
announce 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.
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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
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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 the 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 Angeles, 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
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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.
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SIGNATURE
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report on Form 8-K to be signed on its behalf by
the undersigned hereunto duly authorized.
CALYPTE BIOMEDICAL CORPORATION
Dated: June 9, 1998 By: /s/ John J. DiPietro
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John J. DiPietro
Chief Operating Officer,
Vice President of Finance,
Chief Financial Officer and Secretary
