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August 03, 2015 12:09 PM ET

Healthcare Equipment and Supplies

Company Overview of Standard Diagnostics, Inc.

Company Overview

Standard Diagnostics, Inc. engages in developing, manufacturing, and marketing rapid disease test kits. It offers home health care equipment, such as various rapid test kits to test blood borne diseases, sexually transmitted diseases, malaria, dengue fever, febrile diseases, tuberculosis, respiratory diseases, gastrointestinal infection, fertility harmones, drug of abuse, and bio-terror, as well as cancer markers, cardiac makers, and forensic tests. The company also provides ELISA kits for testing infectious diseases; and urine test products, including urine strips and urine analyzers. In addition, it offers SD BIOLINE HIV/Syphilis Duo test, a solid phase immunochromatographic assay for the ...

156-68 Hagal-dong



Youngin-Si,  449-930

South Korea

Founded in 1999


82 3 1899 9700

Key Executives for Standard Diagnostics, Inc.

Chief Executive Officer
Age: 47
Executive Officer
Age: 61
Vice President
Age: 54
Executive Officer
Vice President
Age: 60
Compensation as of Fiscal Year 2015.

Standard Diagnostics, Inc. Key Developments

Standard Diagnostics and FIND Extend Collaboration to Develop RDT for Malaria and HAT

Standard Diagnostics and FIND have extended their collaboration to include development of a rapid diagnostic test (RDT) for both malaria and human African trypanosomiasis (HAT), or sleeping sickness. FIND also collaborated with SD/Alere to support the recent development of the first RDT for Trypanosoma brucei gambiense HAT, which has already been introduced in many endemic countries and is expected to significantly accelerate elimination of the disease. An RDT that simultaneously tests for malaria and HAT ("a dual test") will become increasingly important as the number of reported HAT cases declines and fewer patients are suspected and therefore tested for the disease. Since all regions where HAT is found are also highly endemic for malaria, a dual test would be much more likely to be used widely and sustainably than a HAT-only RDT, even when the prevalence of HAT is close to zero. FIND's role in supporting SD/Alere's development of a dual test will include collection of clinical samples and leading clinical trials. If it proves effective, it will facilitate detection of residual HAT infections at an early stage, thus eliminating their status as reservoirs, and enhancing the prospects of achieving and sustaining elimination of the disease. This important work will be an extension of the successful partnership that has been established with FIND to support the development and evaluation of tests for HAT, leishmaniasis, Buruli ulcer, tuberculosis and malaria, and reaffirms SD/Alere's commitment to the fight against neglected tropical diseases. Development, evaluation and introduction of the malaria/HAT combo test in endemic countries are being supported by the Bill and Melinda Gates Foundation, with the goal of entering into clinical trials in the second half of 2015.

PATH and Standard Diagnostics Expand Partnership on Dual Detection Test for NTDs

PATH and Standard Diagnostics have expanded their partnership to bring to market a dual detection, or biplex, test for the neglected tropical diseases, or NTDs, onchocerciasis and lymphatic filariasis, or LF. PATH and SD/Alere are working with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, to advance this novel diagnostic test. The new test will build on the momentum of the current partnership between PATH, SD/Alere and NIAID to manufacture and distribute the recently launched SD/Alere SD BIOLINE Onchocerciasis IgG4 rapid test. The new biplex test is based on the detection of antibodies to parasite antigens Ov16 for onchocerciasis and Wb123 for LF. The Ov16 and Wb123 antigens were identified and characterized by scientists at NIAID, which has been working with PATH since 2011 on developing and testing the recently launched river blindness rapid test, Alere SD BIOLINE Onchocerciasis IgG4, and is now extending this work to the biplex test. The dual detection capability of the Ov16/Wb123 biplex rapid test is designed to fill gaps in both onchocerciasis and LF control programs in areas of Africa where the diseases are co-endemic. The Ov16/Wb123 biplex rapid test can be used to support such programs as they move to the disease elimination phase by monitoring postcontrol areas and detecting cases in low-prevalence areas.

Foundation for Innovative New Diagnostics and Standard Diagnostics, Inc. to Co-Develop Second Generation Rapid Test for Human African Trypanosomiasis

FIND (Foundation for Innovative New Diagnostics) and the University of Dundee have signed a Material Transfer Agreement under which new reagents developed by the University will be made available for the development of an improved version of a rapid test for sleeping sickness, a deadly parasitic disease also known as Human African Trypanosomiasis (HAT). A first generation rapid test for HAT was developed by FIND and partners and made commercially available in September 2013. This test is manufactured by Standard Diagnostics, Inc. (SD) and is being introduced in multiple endemic countries as part of new diagnostic strategies to improve early detection of HAT patients. The second generation rapid test will be co-developed by SD and FIND, and will include new antigens that were developed by the University of Dundee and BBI Solutions, who demonstrated their diagnostic potential in prototype rapid tests for sleeping sickness. The new test is planned to be launched in early 2015. Sustainable, large-scale production of the second generation test will be possible because unlike the first generation one it is based on a new format of antigens that are easier to produce. As a result the new test is also expected to be more affordable than the current one.

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