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Calypte Biomedical's Rockville, Maryland Facility Approved for the Manufacture of Its HIV-1 Urine EIA Screening Test

Posted on: Thursday, 8 September 2005, 09:01 CDT

LAKE OSWEGO, Ore., Sept. 8 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation today announced that the United States Food and Drug Administration (FDA) has approved the Company's Rockville facility as the manufacturing site for its HIV-1 Urine EIA screening test.

In 1996, Calypte's HIV-1 Urine EIA became the first, and remains the only, FDA-approved screening test for HIV-1 antibody capable of using urine samples. In mid-2004, the Company announced efforts to streamline and consolidate its operations, which included closing its Alameda, California manufacturing facility and transferring EIA test manufacturing to its Rockville, Maryland facility. The Rockville facility is already FDA-inspected and approved for the manufacture of Calypte's other HIV antibody tests, including its serum and urine HIV-1 Western Blot supplemental tests.

"This favorable response to our application to manufacture the HIV-1 Urine EIA in Rockville is an important accomplishment for several reasons," stated Dr. Richard George, President and CEO. "First and foremost, it means that the Rockville facility is now in a position to continue the uninterrupted supply of this test to our customers in the US and abroad. Second, the proposed sale of our Rockville operations to Maxim Biomedical Corporation is contingent upon, among other things, securing the FDA's approval of Rockville as a manufacturing site for the EIA. This event brings us one step closer to concluding that arrangement and to fully implementing our corporate restructuring plan."

About Calypte Biomedical:

Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. 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 to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. 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-KSB/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.

Calypte Biomedical Corporation

CONTACT: Tim Clemensen for Calypte Biomedical Corporation,+1-212-843-9337, tclemensen@rubensteinir.com

Source: PRNewswire-FirstCall

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