Global Health Products
Chembio has a rich background in the global health diagnostics market. For the past 10 years we have been supplying the developing world with our rapid point-of-care diagnostics. Unlike many other companies, Chembio has always manufactured all of its product in the USA in accordance with FDA cGMP requirements.
Chembio’s products are designed, developed and manufactured in accordance with U.S. FDA Good Manufacturing Practices (GMP). Chembio’s Quality Systems comply with the requirements of ISO 13485:2012, as well as 21 CFR Part 820, U.S. FDA Quality Systems Regulations, and is registered with the FDA under Establishment Registration No. 2431980. Chembio has three FDA approved, CLIA waived rapid POC tests for the detection of HIV 1/2 antibodies and are Pre-Market Application (PMA) approved. HIV 1/2 STAT-PAK® Assay, our SURE CHECK® HIV 1/2 rapid test, and our newly approved DPP® HIV 1/2 Assay for Oral Fluid or Blood. Chembio’s facility is also approved by the United States Department of Agriculture (USDA) for the manufacture of the veterinary tuberculosis tests for which Chembio holds product marketing licenses from the USDA.
Our existing global menu is divided into two areas: Human infectious disease rapid POC tests and animal health rapid POC testing. In the global human diagnostic market we have been primarily focused on HIV. Our initial lateral flow HIV rapid test product line, still widely used today, includes our HIV 1/2 STAT-PAK® Assay, HIV 1/2 STAT-PAK® Dipstick Assay, SURE CHECK® HIV 1/2 rapid test, and our DPP® HIV 1/2 Assay for Oral Fluid or Blood
Our veterinary POC line currently included our unique veterinary tuberculosis line, as well as Leishmaniasis. Certain other veterinary products are in development.
Chembio has a very active product development program based around diverse applications of our Dual Path Platform (DPP®) technology. The applications are focused on a number of new point-of-care (POC) tests for infectious diseases that have global application, as well as certain niche veterinary and other applications. A summary of these R&D programs are provided below.
Multiplex POC Test for the Confirmation of HIV 1 & 2
In addition to our four commercially-available rapid HIV test products (HIV 1/2 STAT-PAK® Assay, HIV 1/2 STAT-PAK® Dipstick Assay, SURE CHECK® HIV 1/2 Assay and DPP® HIV 1/2 Assay), Chembio has continuing research and development activities in the development of next-generation products for the detection and confirmation of HIV.
In 2008 Chembio entered an agreement with Oswaldo Cruz Foundation for this unique product. Evaluations of this product are ongoing, and preliminary data indicate the advantages of multiplexing with this POC technology. The success of this initial 5-band product demonstrates the applicability of this platform to many other potential multiplex applications for confirmation or differential analysis of related analytes, and Chembio is pursuing several of these opportunities with potential partners.
Multiplex DPP® for HIV-Syphilis Assay
Chembio has developed the DPP® HIV-Syphilis Assay, a rapid POC test to determine the presence of both HIV 1-2 antibodies and Syphilis Treponemal pallidum antibodies concurrently. Utilizing its experience and expertise in developing individual tests for both markers, Chembio developed this multiplex product which is now available for export or research use as a quick, reliable diagnostic of both STD infections using the DPP® patented technology.
In 2009 Chembio and the Infectious Disease Research Institute (IDRI) entered into a milestone-based agreement pursuant to which Chembio will use its patented dual path platform technology (DPP®) and other Chembio capabilities to design, develop, and manufacture a low-cost device for the diagnosis of visceral leishmaniasis. This program is funded by IDRI’s in connection with IDRI’s 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.
Chembio is the recipient of a $2.774 million Phase II Small Business Innovative Research (SBIR) grant awarded by the United States National Institutes of Health (NIH) in June 2009 to continue our collaborative work to develop a rapid POC test for Leptospirosis.
There is no effective prevention for human leptospirosis, a life-threatening emerging zoonotic disease, whose global burden is estimated to be as high as 500,000 cases annually.
Globally, TB causes more human deaths than any other single infectious disease, with approximately 95% of cases and 98% of deaths occurring in the developing world. It is estimated that over 2 billion people are infected with the M. tuberculosis bacterium, which is equal to one-third of the world’s population. Mortality is estimated at 3 million annually. The World Health Organization (W.H.O.) estimates that each year another 8 million people worldwide will develop active TB.
Despite the importance of TB as a global public health problem, diagnosis and treatment of the disease still relies on highly inaccurate diagnostic procedures that are more than 100 years old that may not detect as many as 50% of TB cases. Use of culture technology is slow, not readily available in large areas of the developing world, and cost is generally prohibitive. That’s why the development of an accurate, affordable POC test is so important.
Recent Chembio efforts, including activities funded by the Bill & Melinda Gates Foundation through the Foundation of Innovative and Novel Diagnostics, are focused on using antibodies that have been developed for use in a direct antigen detection assay.
TB and HIV interact perniciously, especially in Sub-Saharan Africa where in some countries it is estimated that more than 50% of the population is infected with HIV. Because HIV weakens the body’s immune system, persons with latent TB who are also HIV reactive are at significantly greater risk of converting to active TB than their HIV nonreactive counterparts. In these areas of the world, TB has become the leading cause of death among people with HIV/AIDS.