Calypte Launches International Manufacturing Initiative of its Rapid HIV Type 1 and HIV Type 2 Tests


ALAMEDA, Calif. -- Calypte Biomedical Corporation, a company engaged in developing rapid tests for HIV diagnosis and the developer and marketer of the only two

FDA-approved HIV-1 antibody tests that can be used on urine samples, as well

as an FDA-approved serum HIV-1 antibody Western Blot supplemental test, today

announced that it has entered into an agreement with Adaltis, Inc. to license

and supply certain peptides to Calypte that are owned by Adaltis for the use

in the company's immunodiagnostic assays. The first application for the

peptides will be in the company's HIV rapid diagnostic tests currently under


The agreement provides Calypte with the supply of key, patented HIV-Type 1

and HIV-Type 2 (HIV-1/2) peptides by Adaltis. Calypte's non-exclusive

license to Adaltis' peptide sequences provides the Company total freedom to

operate throughout the world, with the exception of Canada, where Calypte

would work with Adaltis in its home territory. Calypte is licensing the right

to market and sell the peptides as part of the development of its rapid HIV

diagnostic test products.

Dr. J. Richard George, president and CEO of Calypte stated, "We have used

the Adaltis HIV-1/2 peptides in the field trials of our rapid tests in

Thailand. Their consistency provides the foundation necessary to achieve the

high levels of performance we require for both specificity (false negatives)

and sensitivity (false positives). Our field trials have included our blood

rapid HIV-1/2 test for which we filed an Investigational Device Exemption

Application (IDE) in the U.S. last November, as well as our urine rapid HIV-1/2

test. We have also tested the product in house with other fluids and are

pleased with the initial results from both a specificity and sensitivity

perspective and are planning to include this additional product in our

upcoming field trials later this month."

George added, "In the community of like sciences, we were encouraged

to see that OraSure received FDA approval for their laboratory based rapid

oral fluid test for HIV-1. Once our non-laboratory based rapid tests are out

of development and into production, we initially plan to distribute them

outside the United States. We believe that Calypte's products will soon have

world appeal, and after we have introduced our tests internationally, we

expect to file for FDA approval for marketing in the US as well. However, our

current focus is Sub-Saharan Africa and the "next wave" emerging HIV epidemic

countries where the problem is more widespread -- including, China and


Tony Cataldo, executive chairman of Calypte stated, "As Calypte pursues

the development of its rapid HIV-1/2 tests, we believe we are now far enough

along in our development to begin finalizing the necessary agreements and to

start transferring the technology to commercial scale manufacturing. The

largest markets in the world are the emerging markets and we believe we are

now well positioned to serve those markets. "

Calypte currently has a non-exclusive worldwide distribution agreement

with Adaltis Inc. of Montreal, Canada for the distribution of Calypte's serum

HIV-1 Western Blot test.

Calypte Biomedical Corporation is a public healthcare company dedicated to the development and commercialization of in vitro diagnostic tests, primarily for the detection of antibodies to HIV and other sexually transmitted and infectious diseases.

Source: Calypte Biomedical Corporation

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