IDRI and Chembio Collaborate to Develop a Low-Cost Test for Visceral Leishmaniasis

IDRI and Chembio Collaborate to Develop a Low-Cost Test for Visceral
Leishmaniasis

SEATTLE and NEW YORK, May 11 /PRNewswire-USNewswire/ -- The Infectious
Disease Research Institute (IDRI) and Chembio Diagnostics Systems, Inc.
(Chembio) today announced they have entered into a milestone-based agreement
pursuant to which Chembio will use its patented dual path platform technology
(DPP(R)) and other Chembio capabilities to design, develop and manufacture a
low-cost device for the diagnosis of visceral leishmaniasis. This step is
critical to IDRI's program funded under a grant from the Bill & Melinda Gates
Foundation for the development of accurate, rapid and affordable methods of
diagnosis for patients suffering from visceral leishmaniasis in Africa. This
announcement was made at the 96th Annual Meeting of the American Association
of Immunologists (Immunology 2009) held May 8-12 in Seattle, WA.

Most visceral leishmaniasis cases occur in poor populations living in remote
areas far from healthcare centers. In these settings, the disease often
co-exists with malaria and other debilitating parasitic infections that
exhibit similar symptoms, making diagnosis difficult. In these challenging
conditions, the traditional labor-intensive and complex diagnostic procedures
-- invasive removal of bone marrow, spleen and lymph node tissues for
microscopic examination and isolation of the parasite by culture -- are
neither feasible nor field-friendly.

"We are actively working to develop a rapid and simple test that could be used
in the field in Africa to diagnose visceral leishmaniasis by using no more
than a drop of blood," said Dr. Steven Reed, Founder and Head of IDRI's
Research and Development Program. "This would dramatically improve early
detection of visceral leishmaniasis, making current treatments more effective
and decreasing transmission rates."

Rapid diagnostic tests are made of two major components: the reagents which
are selected to react with specific immunologic components present in the
blood of infected patients, and the device which acts as a physical support
for the reagents. Diagnostic devices can be as simple as strips of paper or
plastic cassettes. These simple tests do not require highly skilled laboratory
staff and can be done in the field with results usually available within the
next ten to fifteen minutes.

Curt Malloy, SVP Operations and General Counsel of IDRI said, "Chembio has
significant experience in the development, manufacturing and distribution of
diagnostic tests, particularly in the developing world. IDRI will provide the
reagents for the test and, with our financial support, Chembio will develop a
reliable diagnostic device that can be manufactured at low-cost. This will be
paramount to ensure affordability of the test when ready for implementation."

"We are thrilled to be able to collaborate with IDRI on the complex yet urgent
task of controlling visceral leishmaniasis in developing countries," commented
Larry Siebert, Chairman and President of Chembio. "Working alongside IDRI, we
will apply our DPP(R) and other technologies to create a low-cost diagnostic
device to help fight this disease that has been ignored for too many years,"
commented Javan Esfandiari, Senior Vice President of R&D for Chembio.

About Visceral leishmaniasis

Visceral leishmaniasis (VL) is a serious, potentially lethal, systemic
parasitic illness that has caused epidemics in India, Southeast Asia, Africa
and Latin America. Leishmania parasites are transmitted to humans through the
bite of infected sandflies. Patients with VL develop infections of their
liver, spleen, and bone marrow and may die if the infection goes untreated.
About 500,000 new cases of visceral leishmaniasis occur each year, and 10% of
these patients -- mostly children -- die because their disease cannot be
accurately diagnosed in a timely fashion.

IDRI-Translating science into global health solutions

IDRI is a Seattle-based not-for-profit organization committed to applying
innovative science to the research and development of products to prevent,
detect and treat infectious diseases of poverty. By integrating capabilities,
IDRI strives to create an efficient pathway bringing scientific innovation
from the lab to the people who need it most. For more information, go to
www.idri.org.

IDRI has been working on leishmaniasis for more than 15 years, applying its
expertise to the development of both vaccines and diagnostics. IDRI is
actively developing a therapeutic leishmaniasis vaccine designed to be used in
conjunction with chemotherapy. This candidate vaccine is currently being
tested in several countries. If successful, both diagnostic and therapeutic
tools would complement each other to provide an improved strategy against
leishmaniasis.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing $5 billion point-of-care
testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests
are marketed in the U.S. by Inverness Medical. Chembio markets its HIV
STAT-PAK(R) line of rapid HIV tests internationally to government and
donor-funded programs directly and through distributors. Chembio also has
rapid tests for veterinary tuberculosis and Chagas disease. In 2007 Chembio
received a U.S. patent for its Dual Path Platform (DPP(R)) technology which
has significant advantages over lateral-flow technologies. This technology is
providing Chembio with a significant pipeline of business opportunities for
the development and manufacture of new products based on DPP(R). Headquartered
in Medford, NY, with approximately 100 employees, Chembio is licensed by the
U.S. Food and Drug Administration (FDA) as well as the U.S. Department of
Agriculture (USDA), and is certified for the global market under the
International Standards Organization (ISO) directive 13.485.

SOURCE Infectious Disease Research Institute

Alice Grasset of the Infectious Disease Research Institute, +1-206-330-2553,
agrasset@idri.org; or Susan Norcott of Chembio Diagnostics Systems, Inc.,
+1-631-924-1135, x125, snorcott@chembio.com