(BW) Insurance Industry Beginning To Embrace HIV-1 Urine Test System Companies See Opportunities and Advantages of Urine Test System, Which Offers Safer, More Cost-Effective Alternative to Blood Testing; Calypte Hires Insurance Industry Veteran to Lead Sales Effort

BUSINESS WIRE; Wednesday, August 26, 1998

BERKELEY, Calif.--(BUSINESS WIRE)--Aug. 26, 1998--Calypte Biomedical Corporation (NASDAQ: CALY - news) announced today that six leading U.S. life insurance companies have begun applicant assessment using Calypte's complete Human Immunodeficiency Virus Type 1 (HIV-1) urine test system. In addition, company executives said they expect that at least eight additional leading companies will begin using the test system by the end of the year. Just this June, the U.S. Food and Drug Administration approved the urine HIV-1 Western blot test. The screening test had been approved previously by the FDA. Insurance companies are beginning to turn to the urine test system for a variety of reasons, including:

**Highly accurate results, but lower overall costs than either blood or oral fluid;

**Companies will be able to use urine to test for several risk factors other than HIV infection, including tobacco use, drugs of abuse and many other health-related markers;

**Urine testing does not require a trained health care worker/phlebotomist to collect samples, allowing for agent collection, thus reducing costs and speeding approval times;

**The volume of the urine sample required for a full HIV-1 testing algorithm is less than 2 ml. Laboratories therefore rarely receive samples of inadequate volume, thus avoiding the cost and expense of collecting repeat samples;

**The urine HIV-1 Western blot produces a lower frequency of indeterminate results than any other licensed HIV-1 Western blot;

**Collection devices (urine cups and tubes) are extremely inexpensive, durable and do not have an expiration date;

**Greater consumer acceptance of urine testing over blood testing due to the non-invasive nature of the urine option; and

**The urine of HIV-infected people is highly unlikely to contain infectious HIV-1, and urine testing eliminates accidental needle sticks and other exposure-related dangers associated with blood-borne pathogens, thus protecting both applicants and those collecting the samples.

"The major reasons we decided to adopt the urine test system," said Lee Janecek, Manager of Underwriting Research and Development with Woodmen of the World, "were that it is more cost-effective than blood or oral fluid, collecting urine is more acceptable and understandable to our customers than collecting an oral sample, we can use urine to test for more than just HIV, and we don't have to store kits and put our people through the training and certification required by the oral test. The urine test system also provides us the opportunity to let agents collect the sample, which is important to us when time is an issue. As compared to blood, the less expensive urine system provides a reliable alternative that allows us to continue to provide competitive rates."

The author of a recent On the Risk article called "The Protective Value of Urine Revisited," Richard L. Bergstrom, FSA, MAAA, said: "Given the extremely high sensitivity and specificity of the urine HIV test protocol, and the high internal rates of return achievable at moderate to low face amounts applied for, it's clear that the industry will be taking a close look at this new option." Bergstrom, a consulting actuary for Milliman & Robertson, added, "Insurers, of course, can also use the urine screen to test for other things on a very cost-effective basis. Its non-invasive nature, as well as the fact that urine can be collected in the absence of a paramed, are also clear benefits. Without paramedical fees, the breakeven threshold for the cost-effectiveness of the test is substantially lowered."

The urine test system consists of the HIV-1 enzyme immunoassay (EIA) antibody screening test and the HIV-1 urine Western blot confirmatory test, which detect the presence of antibodies to HIV-1 in urine samples. Clinical studies have shown the urine diagnostic test system to be a highly accurate alternative to blood testing.

-- New Sales Manager Hired --

John DiPietro, COO of Calypte, noted that marketing efforts continue to gain momentum. To help reach other insurance companies, earlier this month Calypte hired Kip Whitefield, a 33-year insurance industry veteran. Whitefield will manage both the sales and customer relations efforts for the insurance sector, drawing upon his accumulated experience with the industry and its players. He most recently served as vice president, national accounts sales manager for ChoicePoint (formerly Equifax, Insurance Services Division). Whitefield will call on the industry's largest companies.

"Obviously, the insurance industry is just one of several we are targeting through our marketing efforts," DiPietro said. "We've also had early interest from other potential users. In addition, we're currently working on a urine rapid test that will utilize much of the same technology as our current FDA-approved test, thus hopefully allowing us to bring a rapid urine test to market quickly."

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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 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.

For more information on how to purchase or evaluate the product, call Dick Van Maanen of Calypte at 510-749-5100.

Visit Calypte on the World Wide Web at: www.Calypte.com

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