| Company Profile |
develops, manufactures and markets rapid tests for the detection of HIV and certain other infectious diseases. The company's current products are based upon single path lateral flow, rapid test technology platforms using proprietary and/or in-licensed technology. Chembio's patented Dual Path Platform (DPP™) is now being employed to develop several new high performance rapid test products in collaboration with others.
Chembio's HIV assays have been incorporated into the World Health Organization (WHO) Bulk Procurement Scheme and the USAID blanket Waiver List which allows them to be procured with U.S. government funds. Two of the company's assays have been approved by the U.S. FDA for sale in the United States. This enables the company to participate in the growing U.S. market which is estimated to be a $50 million market.
Chembio Diagnostic Systems, Inc. operates a cGMP/QS (Good Manufacturing Facility/Quality Systems) manufacturing facility that is registered with the US FDA (Food and Drug Administration). The facility includes dedicated cGMP process manufacturing, Quality Control and R&D laboratories. The company manufactures class II and class III in vitro diagnostic devices.
A commitment to Innovative Partnerships
Strategic alliances are a key element in Chembio’s business strategy. In 2006, Former President Bill Clinton announced that his foundation’s HIV/AIDS Initiative negotiated new pricing agreements to lower the prices of HIV diagnostics and two antiretrovirals (ARVs). These products and pricing include Chembio’s STAT-PAK® HIV 1 / 2 Dipstick. The Foundation’s Procurement Consortium currently includes 50 developing countries around the world.
Read Chembio Press Release -
Former President Clinton Announces New Agreements to
Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs
Chembio announced an agreement in October of 2006 to partner with Inverness Medical Innovations, the global leader in marketing point of care diagnostic tests, for Chembio's FDA-approved rapid HIV tests. The products were launched Q1 of 2007. New CDC recommendations for routine HIV testing and new FDA guidelines that have opened up the over-the-counter market have expanded the U.S. and global market opportunity significantly.
Chembio has initiated strategies to participate in the US President's Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund initiatives. In February 2004, a 13-year technology transfer and supply contract was signed with Bio Manguinhos - one of the world's largest manufacturers of vaccines and an affiliate of the Brazilian Ministry of Health.
In addition, Chembio is collaborating with some of the world's leading scientists in the development of rapid assays for detecting other infectious diseases, both human and veterinary. The company has developed a rapid test for Chagas disease which is endemic in much of Latin America and affects 16 to 18 million people, killing 50,000 annually. The attributes of the Chagas STAT-PAK assay make it ideal for use in resource poor settings. In December 2005, Chembio received a $1.2 million order from an affiliate of the World Health Organization. The assay was used to screen Bolivian children living in areas where the disease is endemic.
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 Commitment to Global Availability
Chembio supplies countries with rapid tests at competitive prices through both traditional and nontraditional distribution channels and builds alliances in developing countries that have been significantly impacted by the HIV pandemic. Due to the rapid spread of HIV/AIDS and the need for increased testing and subsequent ARV treatment in Africa, the company established a Marketing and Business Development Office in the region. Located in Nigeria, this office works closely with both governmental and nongovernmental entities to help provide a sustained supply of HIV rapid tests in the region.
In September 2005, Chembio's HIV 1 /2 STAT-PAK® assay was officially integrated into Uganda's national testing algorithm by the country's Ministry of Health. Currently, the Company's tests have been incorporated into Brazil's and Nigeria's national testing algorithms and are being evaluated in several other countries.
In 2005, the G8 nations declared the goal of getting "as close as possible to universal access to treatment for all those who need it by 2010." As countries scale up antiretroviral therapies to meet the treatment needs of people living with HIV/AIDS, they must also scale up their HIV testing. It is critical that a steady supply of simple, accurate rapid tests are available to meet the increased demand for testing.
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| BOARD OF DIRECTORS |
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Lawrence A. Siebert
President and Director
Mr. Siebert has been Chairman of Chembio Diagnostic Systems, Inc. since 1992 and its President since mid-2002. Mr. Siebert’s background is in private equity and venture capital investing. From 1982 to 1991, he was associated with Stanwich Partners, Inc, which during that period financed and invested in middle market manufacturing and distribution companies. From 1992 to 1999, Mr. Siebert was an investment consultant and business broker with Siebert Capital Corp. and Siebert Associates LLC and was a principal investor in a privately held test and measurement company which was sold in 2002. Mr. Siebert received a JD from Case Western Reserve University School of Law in 1981 and a BA with Distinction in Economics from the University of Connecticut in 1978.
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Alan Carus
Director
Mr. Carus was elected to Chembio’s Board of Directors on April 15, 2005. He is a co-founder of LARC Strategic Concepts LLC, a consulting firm dedicated to guiding emerging companies to next stage development. Prior to co-founding LARC Strategic Concepts LLC, Mr. Carus was Senior Vice President of Maritime Overseas Corporation (“MOC”) and a senior executive of Overseas Ship holding Group, Inc. (“OSG”) from 1981 to 1998 when he retired. MOC was managing agent for OSG, one of the world’s largest ship-owners. He was a member of OSG’s senior management committee and had senior responsibility in areas relating to administration, accounting, tax, finance, budgets, long-range projections, and human resources. Mr. Carus was involved in numerous acquisitions, debt and equity offerings, complex transaction structuring, and was active in the management of OSG's major investments in the cruise industry and other development stage companies. From 1964 to 1981, he was with Ernst & Young (including predecessors), the last seven years as a partner. Mr. Carus has a B.B.A. from the Baruch School of Business of the City College of New York. |
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Gary Meller, MD MBA
Director
Dr. Meller was elected to Chembio’s Board of Directors on March 15, 2005. Since 2001, he has been the president of CommSense Inc., a healthcare business development company. CommSense Inc. works with clients in Europe, Asia, North America, and the Middle East regarding medical information technology, medical records, pharmaceutical product development and financing, health services operations and strategy, and new product and new market development. From 1999 until 2001 Dr. Meller was the executive vice president, North America, of NextEd Ltd., a leading internet educational services company in the Asia Pacific region. He is also a member of the Advisory Board of Crestview Capital Master LLC, which was the lead investor in Chembio’s series B preferred stock private placement. Dr. Meller is a graduate of the University of New Mexico School of Medicine and has an MBA from the Harvard Business School. |
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Katherine L. Davis
Director
Katherine Davis was nominated to serve on the Board of Directors on May 10, 2007. Ms. Davis is presently the owner of Davis Design Group LLC, a company that provides analytical and visual tools for public policy design. Previously she served as the Chief Executive Officer of Global Access Point, a start up company with products for data transport, data processing, and data storage network and hub facilities. From October 2003 to January 2005 Ms. Davis was Lieutenant Governor of the State of Indiana, and from January 2000 to October 2003 was Controller of the City of Indianapolis. From 1989 to 2003 Ms. Davis held leadership positions with agencies and programs in the State of Indiana including State Budget Director, Secretary of Family & Social Services Administration, and Deputy Commissioner of Transportation. From 1982 to 1989 Ms. Davis held increasingly senior positions with Cummins Engine, where she managed purchasing, product cost, manufacturing, engineering, and assembly of certain engine product lines. Ms. Davis serves on the not-for-profit boards of Noble of Indiana, Indiana Museum of African American History, University of Evansville Institute of Global Enterprise, and Purdue College of Science Dean's Leadership Council. She has a Masters of Business Administration from Harvard Business School and a Bachelor Science in Mechanical Engineering from the Massachusetts Institute of Technology. |
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James D. Merselis
Director
James D. Merselis was elected to the Company’s Board of directors on March 20, 2008. From 2002 through 2007 Mr. Merselis was President, CEO and a director of HemoSense, Inc., a point-of-care diagnostic company focused initially on blood coagulation systems for monitoring patients taking warfarin. At HemoSense, he led the Company's development from a pre-revenue, venture-backed start-up through an initial public offering and on to a successful organization selling products in more than 20 countries and a market share exceeding 25% in the U.S. professional segment. In August 2007, Mr. Merselis negotiated the sale of HemoSense to Inverness Medical Innovations. Previously he was President and CEO of Micronics, Inc., where he established key relationships with Amgen, Honeywell and Waytek, and helped transform Micronics from a research project to one focused on commercializing microfluidics tools. Earlier in his career Mr. Merselis was with Boehringer Mannheim, where he advanced through a variety of positions in the U.S. and Europe over a period of more than 20 years, lastly as Senior Vice President and Director of the Company's U.S. Laboratory Diagnostics business. Mr. Merselis holds a Bachelor of Science (Pre-Med) from Nebraska Wesleyan University and an Advanced Management Program Certificate from Harvard Business School. |
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| ADVISORY BOARD |
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Mr. Allen Moore
Mr. Moore is currently a Senior Fellow with the Global Health Council, the world's largest membership alliance dedicated to saving lives by improving health throughout the world. Previously he served as Deputy Chief of Staff and Policy Director for Senate Majority Leader Bill Frist. Mr. Moore's vast experience in public and global health policy comes from years of leadership in the legislative and executive branches of the United States government. His other appointments include serving as Under Secretary of Commerce for President Reagan and as Associate Director of President Ford's White House domestic policy staff. |
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Dr. Peter Anderson
Dr. Peter Andersen is currently Vice President of Vaccine Research and Development at Statens Serum Institut in Copenhagen, Denmark, a highly recognized international research institution whose goal is to control and prevent the spread of infectious diseases and biological threats. Dr. Andersen brings exceptional expertise to Chembio's ongoing efforts to develop a rapid diagnostic test for Tuberculosis (TB). His research has focused on the identification and characterization of novel antigens and immune mechanisms for protection against TB. Dr. Anderson has over 100 keynote presentations and papers to his credit. |
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Dr. Mariano Levin
Dr. Levin currently heads the Laboratory of Molecular Biology of Chagas disease at the Institute for Research on Genetic Engineering and Molecular Biology in Buenos Aires, Argentina. He received a Ph.D. in biochemistry in 1981 from the University of Leipzig, Germany and conducted postdoctoral work in France at INSERM, CNRS, and Institut Pasteur. He has received several prizes from the Argentine Society of Cardiology, and, in 1998 was awarded a John Simon Guggenheim Foundation fellowship. Dr. Levin is a Howard Hughes International Research Scholar. As Full Professor at the School of Science and with the support of the Howard Hughes Medical Institute and the University of Buenos Aires, he created and directs the first genomic facility of this University, CeGA (Center of Applied Genomics). He is also a member of the Board of the South South Initiative (SSI) of the World Health Organization Special Program for Research and Training in Tropical Diseases (WHO - TDR), and the coordinator in the field of Trypanosomiases, including Chagas disease and African Sleeping Sickness. |
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| EXECUTIVE OFFICERS |
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Lawrence A. Siebert
President and Director
Mr. Siebert has been Chairman of Chembio Diagnostic Systems, Inc. since 1992 and its President since mid-2002. Mr. Siebert’s background is in private equity and venture capital investing. From 1982 to 1991, he was associated with Stanwich Partners, Inc, which during that period financed and invested in middle market manufacturing and distribution companies. From 1992 to 1999, he was an investment consultant and business broker with Siebert Capital Corp. and Siebert Associates LLC, and was a principal investor in a privately held test and measurement company which was sold in 2002. Mr. Siebert received a JD from Case Western Reserve University School of Law in 1981 and a BA with Distinction in Economics from the University of Connecticut in 1978. |
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Richard J. Larkin
Chief Financial Officer
Mr. Larkin oversees Chembio’s financial activities and information systems. He has been Chief Financial Officer of Chembio Diagnostic Systems, Inc. since September 2003. Prior to joining Chembio Diagnostic Systems Inc., Mr. Larkin served as CFO at Visual Technology Group from May 2000 to September 2003. He led their consultancy program providing hands-on expertise in all aspects of financial service, including initial assessment of client financial reporting requirements within an Enterprise Resource Planning (Manufacturing) environment. Prior to joining VTG, he served as CFO at Protex International Corporation from May 1987 to January 2000. Mr. Larkin holds a BBA in Accounting from Dowling College and is a member of the American Institute of Certified Public Accountants. |
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Cathy Dudnanski
VP, Marketing
Ms. Dudnanski joined Chembio in 2005 as Marketing Director for the human diagnostics products including assays for HIV 1/ 2 and Chagas disease. She was promoted to Vice President in 2007. Ms. Dudnanski brings over 20 years of domestic and international marketing & sales experience in medical devices and diagnostics to the company. Prior to joining Chembio, Ms. Dudnanski was a marketing manager for GE Healthcare and has served in senior marketing and sales positions for several diagnostics firms. She
received a B.S in Medical Technology from Roanoke College and an MBA from Loyola. Ms. Dudnanski is a registered medical technologist and a member of the American Society of Microbiology. |
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Les Stutzman
VP, Marketing
In 2005, Mr. Stutzman joined Chembio as Vice President of Marketing to lead the development and launch of rapid tests for veterinary and human TB and other veterinary products. Mr. Stutzman has spent over twenty years in marketing leadership positions within various diagnostics companies. He has held Global Director and Business Development Director positions in Marketing for diagnostic companies including bioMérieux Inc., (formerly Organon Teknika Corp.), Durham, North Carolina and TREK Diagnostic Systems, Cleveland, Ohio. Mr. Stutzman received his MBA in Marketing from Duke University Fuqua School of Business in 1988 and his Masters in Microbiology from Wagner College in 1982. Mr. Stutzman is MT (ASCP) SM certified. |
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Javan Esfandiari
VP, Research & Development
In 1993 Mr. Esfandiari co-founded, and became a co-owner of Sinovus Biotech AB where he served as Director of Research and Development for lateral flow technology until Chembio Diagnostic Systems, Inc. acquired Sinovus Biotech AB in 2000. From 1993 to 1997, Mr. Esfandiari was Director of Research and Development with On-Site Biotech/National Veterinary Institute, Uppsala, Sweden, which was collaborating with Sinovus Biotech AB on development of veterinary products using lateral flow technology. Mr. Esfandiari received his B.Sc. in Clinical Chemistry and his M. Sc. in Molecular Biology from Lund University, Sweden. |
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Richard Bruce
VP, Operations
Mr. Bruce has been VP of Operations since April 2000. In this capacity, he directs Chembio’s production, maintenance, inventory, shipping and receiving, and warehouse operations. From 1998 to 2000, Mr. Bruce was a senior manager at V.I. Technologies. From 1993 to 1998, he held various management positions at Biomerieux. Mr. Bruce held director level positions at American Home Products from 1984 to 1993. Mr. Bruce has over 25 years of operations management experience with Fortune 500 in vitro diagnostic and blood fractionation companies. Mr. Bruce received his BS in Management from National Louis University in 1997. |
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Tom Ippolito
VP, Regulatory Affairs, QA & QC
Mr. Ippolito joined Chembio in June 2005. He has over 20 years experience with in vitro diagnostics for infectious diseases, protein therapeutics, vaccine development, Process Development, Regulatory Affairs and Quality Management. Over the years, Mr. Ippolito has held Vice President level positions at Biospecific Technologies, Corp., Director level positions in Quality Assurance, Quality Control, Process Development and Regulatory Affairs at United Biomedical, Inc. Mr. Ippolito is also the Course Director "drug development process" and "FDA regulations", a BioScience Certificate program at New York State University of Stony Brook. |
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Robert L. Aromando, Jr.
Senior Vice President, Commercial Operations
Bob Aromando was Vice President of Marketing for Bracco Diagnostics Inc., a Princeton, New Jersey-based pharmaceutical company and part of the Bracco Group. Most of his focus at Bracco was on managing the efforts of a marketing department, launching new products, business development and life cycle management. Bob joined Bracco in November 2001 after completing a one-year contract as interim President and Chief Executive Officer for American Bio Medica Corporation, a publicly-traded diagnostic healthcare company. Prior to American Bio Medica Corporation, Bob was Director of Global Marketing for Covance, a leading pharmaceutical development organization headquartered in Princeton, New Jersey where is had responsibility for managing the strategic direction of the clinical development marketing department. He also spent eight years at Roche Diagnostic Systems (member of the Roche Group) as Director of Global Marketing responsible for the drugs of abuse business unit. His focus at Roche was allocated to government affairs as well as providing solutions for substance abuse programs in the workplace, criminal justice, drug treatment and school sectors. Bob’s career in healthcare also included stints at American Home Products and Litton Bionetics Laboratory Products. |
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| MEMBERSHIPS & AFFILIATIONS |
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