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Calypte Biomedical and Becton, Dickinson and Company Announce New One-stop Testing Service.

Business Editors & Health/Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--Dec. 4, 2000

New One-stop Testing Service Detects Chlamydia Trachomatis and

Neisseria Gonorrhoeae Using BDProbeTec(TM) ET CT/GC Amplified DNA

Assays and HIV-1 Antibody Using Calypte's HIV-1 Antibody Tests

From a Single Urine Sample

Calypte Biomedical Corporation (NASDAQ: CALY) announced a joint promotional effort together with BD (Becton, Dickinson and Company) (NYSE:BDX) today.

The two companies are to co-promote the Sentinel(TM) family of testing services for urine-based testing for three important sexually transmitted diseases (STDs): human immunodeficiency virus (HIV), chlamydia, and gonorrhea. The Sentinel(TM) Testing Service is currently the only service to offer urine-based HIV type 1 (HIV-1) antibody testing alone or in combination with urine-based chlamydia and gonorrhea testing. This exciting partnership enables all three of these STDs to be detected rapidly at a competitive cost.

Urine specimens are versatile and can be used in a wide range of tests, eliminating the pain and fear associated with needles used for HIV testing or the invasive and uncomfortable aspect of urogenital swab collection for STDs. The use of urine also eliminates the potential transmission of HIV-1 from blood, since urine is reportedly free of infectious HIV-1(1,)(2).

The Sentinel(TM) Testing Service has been created(3) to simplify the logistics of multiple STD testing and to eliminate the trade-off between cost and turnaround time that is commonly faced by healthcare providers. The goal of the program is to offer a service that utilizes the best technology for all patients at a price at or below Medicaid reimbursement rate in most states.

All three tests used by the Sentinel(TM) Testing Service are FDA-licensed or cleared for use with urine samples. BD's innovative BDProbeTec(TM) ET system using DNA amplification test methodology is the Sentinel(TM) choice for chlamydia and gonorrhea testing. DNA amplification technology is considered to be more sensitive and specific than conventional non-amplified tests and can identify a number of infections that would previously have gone undetected and hence untreated. The test methodology used by Sentinel(TM) for HIV-1 antibody detection is the Calypte HIV-1 Urine EIA (enzyme immunoassay), automatically supplemented by the Cambridge Biotech HIV-1 Antibody Urine Western Blot when necessary, and is the only FDA-licensed urine-based HIV-1 antibody test available.

This single-sample, urine-based test for all three of these STDs has enormous implications for improving patient care and public health. Studies have shown that the need for a blood sample or an invasive urogenital swab can discourage men and women from being tested for STDs. In contrast, urine specimens are easy to donate and can be collected anywhere by individuals without specific medical training, thus enabling more community outreach programs and epidemiologic studies.

The tests must be ordered by licensed medical professionals and are simple to order through the Sentinel(TM) website, either online or by downloading a printable order form, or by phone. Urine collection kits provided to those ordering a test include a urine collection cup, two transport tubes, a sample pipettor, an express mailer, an instruction sheet and color-coded barcodes that identify both the patient sample and the service requested.

"We welcome this new co-marketing effort with Calypte and aim to raise the awareness among the healthcare community about the benefits of urine-based testing. Ultimately, we hope our marketing efforts will help improve screening for these diseases and present an overall cost-effective advance in the fight to reduce these STDs," said Rich Pinnola, Director of Molecular Marketing at BD Diagnostic Systems.

"Calypte believes that accurate, non-invasive, urine-based testing methods for HIV and other chronic diseases have made and will continue to make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly", said Richard R. VanMaanen, Calypte Director, Marketing, Sales and Business Development.

BD is a medical technology company that manufactures and sells a broad range of supplies, devices, and systems for use by healthcare professionals, medical research institutions, industry, and the general public.

Calypte Biomedical Corporation (NASDAQ: CALY), 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 chronic illnesses. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-licensed 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 chronic 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 sells its products in over 40 countries worldwide through international distributors and strategic partners.

Note: Every state requires the testing laboratory to report positive chlamydia and gonorrhea results by name (or provider-assigned code), along with demographics, to the pertinent Health Department authorities. Where anonymous HIV-1 testing is permitted, Sentinel(TM) HIV-1 Anonymous results will be reported to the healthcare provider by barcode only.

1. Kawashima H, Bandyopadhyay S, Rutstein P, Plotkin SA. Excretion of human immunodeficiency virus type-1 in the throat but not in urine by infected children. J Pediatrics. 1991;118:80-82.

2. Skolnik PR, Kosloff BR, Bechtel LJ, et al. Absence of infectious HIV-1 in the urine of seropositive viremic subjects. J Infect Dis. 1989;160:1056-1060.

3. The Sentinel(TM) Testing Service was launched by Calypte Biomedical Corporation in May, 2000 and is facilitated by the Clinical Reference Laboratory (CRL) Lenexa, KS. Calypte markets the SentinelTM Testing Service. Further details about Sentinel can be found at

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding insurance company adoption of the urine testing products and statements regarding marketing and distribution arrangements and plans. 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, the Company's ability, directly or through third parties, to successfully manufacture and market the urine testing products and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. 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 which may impact the Company's success are more fully disclosed in the Company's most public filings with the U.S. Securities and Exchange Commission.
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Publication:Business Wire
Date:Dec 4, 2000
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