Greetings CALY loyalists, Here's a news release: Monday October 19, 12:08 pm Eastern Time Company Press Release MetLife and Country Life Insurance Among 20 Life Insurance Companies Using Urine HIV Test Companies See Urine Test System Offering a Safer, More Cost-Effective Alternative to Blood Testing BERKELEY, Calif.--(BUSINESS WIRE)--Oct. 19, 1998-- Calypte Biomedical Corporation (NASDAQ:CALY - news) announced today that MetLife and Country Life Insurance are among the 20 leading U.S. life insurance companies that have begun applicant assessment using Calypte's complete Human Immunodeficiency Virus Type 1 (HIV-1) urine test system. Calypte executives said they expect that several additional insurance companies will begin using the urine test system by the end of the year. In 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.
''Using the urine HIV test system simply makes good sense from all perspectives,'' said Nancy Haley, Ph.D., assistant vice president and laboratory director for MetLife, one of the country's two largest insurance companies. ''Many of our policies already required a urine sample to conduct other tests for risk assessment. So, using urine for testing HIV is a perfect add-on test.''
''Previously, we were using the finger stick test for HIV. We've conducted our own research and are very satisfied with how well the urine test works. Now, there's no reason to stick people's fingers, a fact our field force is very excited about,'' Dr. Haley added. ''Paramedics were already collecting other samples for us. Also, a lot of people don't want to give blood, and that doesn't help our MetLife representatives sell policies. Bottom line, the urine test really seems to simplify our lives.'' Several of Metropolitan's affiliate companies are already using Calypte's urine HIV test.
Country Life Insurance, the life insurance division of Country Companies, began using Calypte's urine HIV test in September 1998. The Bloomington, Illinois-based company will have its agents manage sample collection. Company executives stated that using the urine HIV test enables it to test more of its applicants.
''Having these high-caliber life insurance companies decide to use our HIV urine test is a tremendous validation and acceptance of the test and all of its advantages,'' stated Bill Boeger, president and CEO of Calypte Biomedical. ''We're currently shipping 40,000 tests a month to our insurance customers -- a number with which we're very pleased, especially considering we just received FDA approval in June. Obviously, this is one of several important markets we've targeted for the urine test.''
Some of the many reasons insurance companies are adapting the urine test system include:
-- Highly accurate results; -- Lower overall costs (in many instances) 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 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 author of a recent On the Risk article called ''The Protective Value of Urine Revisited,'' Richard L. Bergstrom, FSA, MAAA, said: ''It's not surprising that the insurance industry is embracing the urine test modality, considering the high internal rates of return achievable at moderate to low face amounts applied for and given the extremely high sensitivities and specificities of the test components.'' Bergstrom, a consulting actuary for Milliman & Robertson, also stated, ''The urine screens can also be used to cost-effectively test for many things, in addition to HIV. Also, its non-invasive nature is a positive to both health-care professionals and to potential policyholders. In addition, urine can be collected in the absence of a paramedic. Even in cases where paramedics collect the urine, they usually charge less than when they collect blood because no venipuncture is required.''
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.
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
-------------------------------------------------------------------------------- Contact:
Calypte Biomedical Bill Boeger, John DiPietro 510/749-5100 or Healy Communications Jason Sherman, David Schulte 312/440-3900
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