Calypte Gains Distribution Rights for FDA-Cleared Urine Test of Liver Function; Exclusive Rights for US and Canada Insurance Market Business Wire
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Calypte Gains Distribution Rights for FDA-Cleared Urine Test of Liver Function; Exclusive Rights for US and Canada Insurance Market

Business Wire - June 11, 2002


ALAMEDA, Calif.--(BW HealthWire)--June 11, 2002--Calypte Biomedical Corporation (OTCBB:CALY) announced today that it has executed an agreement with Marukin Diagnostics, Inc. of Berkeley, California for the distribution of Marukin's urinary bile acid sulfate (UBAS) assay. Bile acid levels in urine are a useful marker of liver function.

The agreement gives Calypte exclusive rights to market Marukin's assay to the insurance industry in the United States and Canada, with options for additional territories in the future. The assay can be performed on a wide variety of popular automated analyzers and has FDA 510(k) clearance so it can be marketed immediately. It is estimated that there are 6-8 million insurance applicants tested each year in the US for liver function, representing a potential multi-million dollar market.

Anthony Cataldo, Executive Chairman of Calypte, said, "In the insurance market, UBAS is a great complement to our urine HIV-1 antibody tests. Like the urine HIV-1 test, UBAS could extend the protective value of urine testing in ways never before possible. We see the ability to get increasingly more comprehensive information from a urine sample as a good thing for everyone -- it helps insurers keep their costs and premiums down, and eliminates the pain and inconvenience of blood draws for insurance consumers."

According to Donald Ketley, PhD, President of Marukin Diagnostics, "UBAS has been shown in clinical trials to be effective as a general marker of liver function in subjects known to be suffering from a variety of liver problems. We worked with one of the nation's largest insurance applicant testing laboratories to investigate the assay's performance characteristics on over 3,000 subjects, and concluded that this test could be a cost-effective alternative to blood drawing for insurers as a risk assessment tool."

"Although UBAS is a marker of liver function in general, for the purposes of this study, we looked at the relationship between elevated UBAS and Hepatitis C infection, which is a growing concern of life and disability insurers. We calculated that in the population evaluated, the test had enormous (99.6%) negative predictive value for HCV. In other words, if you test a subject's urine and find no UBAS elevation, you would have a 99.6% probability that the subject is not HCV-infected. When UBAS is used in conjunction with the traditional blood test ALT, there is a 50% increase in the number of HCV positive patients detected compared to the use of ALT alone as a screen," Ketley added.

Additional technical information about the performance of UBAS can be found in an article titled: "An Analysis of UBAS as a Urinary Liver Function Marker," published on the Knowledge Digest website (www.knowledgedigest.com).

Marukin Diagnostics is a wholly owned subsidiary of Marukin-Chuyu, Co. LTD of Osaka, Japan. Marukin-Chuyu is publicly traded on the Osaka Securities Exchange and has sales of 11,364 million yen ($91 million US).

Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. Current product labeling including specific product performance claims can be found on our website at www.calypte.com.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue to expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K for the year ended December 31, 2001, and its subsequent filings with the SEC.

CONTACT: Sitrick and Company, Los Angeles Joe Bunning, 310/788-2850

SOURCE: Calypte Biomedical Corp.


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