Chembio has a very active product development program all based around diverse applications of its 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. Chembio’s products are designed, developed and manufactured pursuant to a quality system which is certified under ISO 13485 and in accordance with US FDA Good Manufacturing Practices (GMP). Chembio is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations and is registered with the FDA under Establishment Registration No. 2431980. Chembio’s has two FDA approved Pre-Market Applications for its HIV tests. 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.
GLOBAL HEALTH PRODUCTS
Multiplex POC Test for the Confirmation of HIV 1 & 2
In addition to its four commercially available rapid HIV test products (HIV 1/2 STAT-PAK®, HIV 1/2 STAT-PAK® Dipstick, Sure Check® HIV 1/2 and DPP® HIV 1/2 Screen), Chembio has continuing research and development activities in the development of next generation products for the detection and confirmation of HIV.
[picture of 5 band test]
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.
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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.
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 sand flies. 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 VL occur each year, and 10% of these patients — mostly children — die because their disease cannot be accurately diagnosed in a timely fashion.
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. |
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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. Untreated leptospirosis often progresses to multi-organ failure and/or pulmonary hemorrhage, and prompt diagnosis and early initiation of antibiotic therapy are the key intervention to prevent the morbidity and mortality associated with these complications. We will receive approximately 65% of the grant proceeds over a three year period beginning June 2009. Development of the test has been in collaboration with Weill Medical College of Cornell University in New York and the Oswaldo Cruz Foundation in Brazil, the largest research institution in Latin America.
In the one year Phase I study which we completed in 2008 we identified novel diagnostic targets, applied them to our DPP®, and found that a DPP® prototype had an overall sensitivity of 85% and specificity of 90% in evaluations of samples from leptospirosis patients from Brazil and Thailand. Furthermore, the DPP® prototype had a sensitivity of 78% in identifying leptospirosis in the first 7 days of illness, the "window-of- opportunity" during which initiation of antimicrobial therapy provides greatest benefit. In the Phase II study our goal is to fully develop and evaluate a rapid diagnostic test for leptospirosis which will have required characteristics for general use worldwide. |
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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. Currently, a diagnosis of TB most often relies on Acid Fast Bacillus (AFB) smear technology from multiple sputum samples, developed by Robert Koch in 1882. However, this test may not detect as many as 50% of TB cases. Use of culture technology is slow (taking 3-4 weeks or longer) and not readily available in large areas of the developing world. Additionally, its cost is generally prohibitive in most cases. Reliance on X-Ray technology is highly insensitive as the technology can’t differentiate TB from Cancer or other pneumonias. Newer technologies are on the horizon, but they are both technologically demanding and expensive.
Alternative technologies that may supplement smear screening and increase the overall detection rate of TB include antibody and antigen detection tests. Previous Chembio efforts were focused on antibody detection tests using carefully selected reagents. More recent 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. 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. TB is a chronic bacterial infection that is spread in humans through the air and usually infects the lungs, although other organs are sometimes involved. Most persons who are infected with TB are asymptomatic (i.e., latent TB), with a relatively small percentage subsequently developing symptoms of the disease – i.e., active TB. The World Health Organization (WHO) estimates that each year another 8 million people worldwide will develop active TB. Mortality is estimated at 3 million annually.
The WHO estimates that human TB morbidity and mortality for the 1990’s was 88 million and 30 million, respectively, with similar predictions for the current decade unless policies and practices in detection and treatment are dramatically altered. Most cases of TB occur in developing countries, 22 of which (mostly in Southeast Asia and Africa) have been designated “high prevalence endemic countries”.
The economic effects of TB are devastating, both for individuals and communities. The disease tends to strike individuals in their most productive years of 15-50. The adverse financial impact due to the potential loss of family income coupled with the expense of transportation to get to often distant health facilities for treatment and the cost of administering and monitoring TB for 6-9 months of daily therapy (i.e., DOTS) all conspire against both the macro-economy (i.e., society as a whole) as well as the micro-economy (i.e., family or individual) of those developing countries least able to afford it. Yet with the right treatment TB can be cured for less than $20.00 per patient. The worldwide annual cost of TB control is estimated to be $4 Billion.
As a highly contagious, air-borne disease, transmission of TB usually results from close or casual contact with infected persons. When an infected person sneezes, coughs, spits, or talks they disseminate TB microorganisms that can be inhaled. Once introduced into the lungs, TB is able to avoid being destroyed by the body’s macrophages or granulomas specialized cells of the immune system that destroy many bacteria, viruses, and other foreign bodies. As a result, the bacteria are able to spread throughout the newly infected person’s body, multiply, survive, and remain dormant for years. This stage of TB is called Latent TB. Active TB occurs when the bacteria infiltrate organ systems, the most common being the lungs (pulmonary TB). Clinical symptoms of TB include severe coughing, chest pain, blood in the sputum, acute weight loss, fever, and chronic fatigue.
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. |
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