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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