About Chembio
INNOVATION and PRIDE
Chembio has a passion to innovatively develop, manufacture, license, and market point-of-care (POC) diagnostic tests and technology for the detection of infectious diseases. We were founded in 1985 and entered the POC testing field in the late 1990’s, and are proud to claim two out of only four HIV 1-2 rapid test devices that are FDA approved and CLIA waived for use.
CHEMBIO’S PATENTED DUAL PATH PLATFORM (DPP®)
DPP® enables development of POC assays that provide unique features and capabilities such as multiplexing and improved control of challenging sample types such as oral fluid. Several new tests have already been developed on DPP® including a recently FDA Pre-Marketing Application (PMA)-approved oral fluid HIV 1/2 test, and a CE Marked combination screening and confirmation test for Syphilis. Our pipeline of products includes a combination DPP® HIV 1/2 and Syphilis POC test, and a Hepatitis-C POC test. Future POC tests under consideration include tests for pre-natal markers and POC tests for use in the veterinary field, and an over-the-counter consumer test for HIV.
Chembio is therefore well-positioned to participate in the broader growing global market for POC diagnostic testing with this patented technology. The demand for point-of-care diagnostic products is increasing as a way to improve prevention efforts and thereby lower the costs of healthcare through earlier, easier, and faster diagnosis. Our products serve diverse markets that are global.
Chembio believes strongly that its DPP® technology combined with its core manufacturing competencies will enable the development of many next-generation rapid tests.
CORE STRENGTHS
Chembio’s core strengths are in its research, development, quality control, and manufacturing expertise. In certain instances partnerships have been forged with leading global health or marketing organizations.
Chembio’s rapid POC HIV tests have been selected in the national testing protocols of several countries on all continents. International relief efforts, led by the President’s Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund to Stop HIV, TB and Malaria (the Global Fund), have made significant strides toward the prevention and treatment of HIV/AIDS, for which rapid HIV tests are an essential component.
PARTNERSHIP
In 2007, Chembio entered the United States rapid HIV test market. The Company’s two HIV tests that are FDA approved and CLIA waived are based on lateral flow technology and are marketed exclusively in the U.S. by Alere Inc. under their Clearview® brand as HIV 1/2 STAT-PAK® and Complete HIV 1/2. Chembio participates in the global HIV rapid testing market with various strategic partners and distributors worldwide.
Chembio also has the unique expertise in completing and executing technology transfer agreements in the international market for rapid tests. These agreements ensure a cost-effective means of providing local public health programs with needed POC screening and confirmatory tests by transferring know-how for the products that will ultimately be manufactured locally by Chembio’s customer. At the same time, these agreements provide qualified public and private entities with the ability to effectively address local conditions. To date, Chembio has concluded five such agreements with Bio-Manguinhos, an agency that is part of the Oswaldo Cruz Foundation (FIOCRUZ) and that is affiliated with the Brazilian Ministry of Health; other such agreements are in discussion for this and other markets.
GRANTS, AGREEMENTS, AND RESEARCH
Chembio is a party to several grants and other funded contract research and development agreements with entities that have included the United States National Institutes of Health (NIH), the United States Centers for Disease Control (CDC), the Foundation for Innovative and Novel Diagnostics (FIND), and the Infectious Disease Research Institute (IDRI). Work with these organizations involves efforts to develop rapid POC tests, all on DPP®, for Tuberculosis, Malaria, Leprosy, Leishmaniasis, Leptospirosis, Syphilis, HIV, Influenza, and other conditions in humans and animals. In each instance there is a demonstrated need for a simple, accurate, cost-effective rapid diagnosis at the point of care.
THE FUTURE
Chembio Chembio has a robust pipeline of new products and technologies that it believes will continue to fuel its growth. In the near and medium term, our FDA PMA-approved DPP® HIV 1/2 (for use with oral fluid or blood samples), DPP® Syphilis Screen & Confirm , DPP® HIV syphilis combo, Hepatitis-C, and OTC HIV POC tests are anticipated to provide that growth. Longer term, we have a number of exciting projects, technologies, and markets that we can participate with our patented technology combined with our product development and manufacturing expertise.
FINANCIAL PERFORMANCE
Chembio is a profitable company. Our revenues have grown steadily since 2003, and at a compounded average annual growth rate of 33%, from 2006 to 2011 when revenues approached $20 million. Chembio is a public company and its shares are registered with the United States Securities and Exchange Commision. In June 2012 Chembio’s common stock was listed on NASDAQ where its common stock is traded under the symbol CEMI.
OUR HOME
All of Chembio’s activities are conducted by its approximately 170 employees from a 30,000-square-foot leased facility in Medford, (Long Island) NY. The facility is registered with both the United States Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA). Chembio’s products are designed and manufactured in accordance with these agencies’ relevant quality standards as well as ISO-13.485.
Chembio Diagnostic System Inc.