Chembio Diagnostic Systems, Inc.

3661 Horseblock Road , 11763 Medford, NY
USA

Telephone +1 631 9241135-100
Fax +1 631 9242065
info@chembio.com

This company is co-exhibitor of
Messe Düsseldorf North America

Trade fair hall

  • Hall 3 / C30-16
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand C30-16

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostics
  • 03.05  Infectious Immunology
  • 03.05.08  Rapid tests - Infectious immunology

Rapid tests - Infectious immunology

Company news

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Oct 11, 2016

Robert Passas Ph.D. Appointed President, EMEA and APAC Regions

October 11, 2016
Chembio Expands Global Commercial Operations Leadership
 

Robert Passas Ph.D. Appointed President, EMEA and APAC Regions
Sharon Klugewicz Appointed President, Americas Region

MEDFORD, N.Y., Oct. 11, 2016 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, announced today the appointment of two senior leadership positions to support the expansion of the company's global commercial operations.  Effective today, Robert Passas, Ph.D., has joined the company as President, EMEA and APAC regions, with responsibility for commercial operations in Europe, Middle East, Africa, and Asia.  Sharon Klugewicz, most recently the Company's Chief Operating Officer, has been promoted to President, Americas region, with responsibility for commercial operations in the United States, Latin America, and Canada. 

Dr. Passas joins Chembio today, bringing an established track record and expertise in clinical diagnostics, which includes over 25 years of general management and commercial operations. As President of Chembio's EMEA and APAC regions, he will be responsible for sales, marketing, and customer support and will be tasked with establishing regional sales and marketing, building country-specific distribution channels, and increasing sales throughout the regions. Prior to joining the company, he held positions of increasing responsibility at Abbott, Quidel, The Binding Site, and Trinity Biotech. In his most recent position, he was responsible for worldwide marketing and international sales at Trinity Biotech. Dr. Passas holds a B.S. in medical biochemistry and a Ph.D. in analytical chemistry from the University of Surrey, U.K.

Chembio CEO John Sperzel commented, "We are delighted to add someone of Bob's caliber to our commercial leadership team at a time when our product portfolio is expanding beyond sexually transmitted disease, to include future POC tests for fever and tropical diseases such as Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa and Marburg. He has significant industry experience in commercial operations, having worked for several of the world's leading diagnostic companies, and a track record of building highly effective worldwide sales and marketing teams. We expect Bob to make an immediate impact by creating the framework for commercial success throughout the EMEA and APAC regions."

Ms. Klugewicz joined Chembio in 2012 and demonstrated success and leadership in multiple roles, including her most recent position as Chief Operating Officer. As President of Chembio's Americas region, she will be responsible for sales, marketing, customer support, clinical and regulatory affairs, and quality systems in the Americas, and will be tasked with leading the U.S. commercial team and expanding commercial operations throughout Latin America, the U.S. and Canada. Prior to joining the company, she spent 20 years at Pall Corporation where she held positions of increasing responsibility, including Senior Vice President, Scientific and Laboratory Services. Ms. Klugewicz received a B.S. in Neurobiology from Stony Brook University and a M.S. in Biochemistry from Adelphi University.

Mr. Sperzel further commented, "Since joining Chembio, Sharon has established a track record of success in a number of areas, including manufacturing, product development, regulatory affairs, and quality systems. I've had the pleasure of working closely with her since 2014, and she has demonstrated the right combination of skills, knowledge and attributes to assume the leadership of commercial operations in the Americas region."

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors.  The Company's SURE CHECK® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview®Complete HIV 1/2 Assay.

Chembio has developed a patented point-of-care (POC) test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.

Forward-Looking Statements

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.

Contact:

Robert Passas
President EMEA, Asia Pacific
Chembio Diagnostic Systems, Inc.
email:  RPassas@chembio.com

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Jul 27, 2016

Chembio's DPP® Zika IgM/IgG Assay Obtains CE Mark for Rapid Point-of-Care Detection of Zika Virus

July 27, 2016
Chembio's DPP® Zika IgM/IgG Assay Obtains CE Mark for Rapid Point-of-Care Detection of Zika Virus
Sales of DPP® Zika IgM/IgG Assay Anticipated in Second Half of 2016
 

MEDFORD, N.Y., July 27, 2016 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has obtained a CE mark for its DPP® Zika IgM/IgG Assay. The Chembio DPP® Zika IgM/IgG System, which includes an assay utilizing the patented DPP® technology, as well as a digital reader, the DPP® Micro Reader, are now cleared for commercialization and for sale in 17 European countries, including the United Kingdom, Germany, and France, as well as a majority of the Caribbean nations, not including Puerto Rico.

Chembio's DPP® Zika IgM/IgG Assay detects antibodies from a 10uL fingerstick sample and provides quantitative results in 20 minutes, using the Company's patented Dual Path Platform (DPP®) technology. The DPP® Zika IgM/IgG Assay is the first POC Zika test to obtain CE mark, and the Company expects to launch sales of the product in the eligible European and Caribbean nations during the second half on 2016.

Zika virus is a mosquito-borne virus that was first identified in Uganda in 1947. It is believed that the virus is transmitted to humans through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti, the same mosquito that transmits dengue, chikungunya and yellow fever. On January 22, 2016, the Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) to respond to outbreaks of Zika occurring in the Americas and increased reports of microcephaly and Guillain-Barré syndrome in areas affected by Zika. On February 1, 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC) because of clusters of microcephaly and other neurological disorders in some areas affected by Zika. On February 8, 2016, CDC elevated its EOC activation to a Level 1, the highest level. Since 2015, Zika outbreaks have been recorded in more than 60 countries and territories, with symptoms similar to other arbovirus infections such as dengue, and include fever, skin rashes, conjunctivitis, muscle and joint pain, malaise, and headache.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to report our obtaining of the CE mark, and we look forward to initiating sales of our DPP® Zika IgM/IgG Assay and DPP® Micro Reader, which we anticipate in both the eligible European and Caribbean nations during the second half of 2016. We are hopeful that our DPP® Zika IgM/IgG Assay and DPP®Micro Reader become valuable tools to address global health emergencies posed by emerging fever diseases such as Zika virus. The DPP® Zika IgM/IgG Assay has been on an accelerated product development schedule, and our early success is in large measure the result of initial funding from the Paul G. Allen Family Foundation, a versatile DPP® technology platform, Chembio's scientific expertise, a global network of collaborations which enabled access to clinical specimens, and the positive interaction with regulatory agencies."

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors. SURE-CHECK® HIV 1/2 Assay previously has been sold in the U.S. exclusively as Clearview® COMPLETE HIV 1/2 Assay.

Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.

Forward-Looking Statements

Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission. 

Contact:

Robert Passas
President EMEA, Asia Pacific
Chembio Diagnostic Systems, Inc.
email:  RPassas@chembio.com

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About us

Company details

Chembio, founded in 1985, develops, manufactures, licenses, and markets point-of-care (POC) diagnostic tests and technology for the detection of infectious diseases and other medical conditions.

Chembio participates in the global HIV/Syphilis rapid testing market with strategic channel partners worldwide. We are now expanding distribution channels.

Chembio manufactures several U.S. FDA-approved, CE-Marked, WHO Prequalified and USAID Approved HIV 1/2 and Syphilis tests and just launched the DPP® Zika IgM/IgG System (Assay and Reader), CE-marked.

Chembio’s DPP® HIV 1/2 Assay works on oral fluid or any blood matrix and is based on our proprietary Next Generation DPP® Technology Dual Path Platform technology. It detects the presence of HIV 6 days earlier than the current oral fluid rapid test. DPP® technology enables multiplexing and improved sensitivity.

Chembio also offers a USAID Approved rapid DPP® HIV-Syphilis assay – a dual test requiring only one patient fingerstick sample of 10 µL.

Chembio's other FDA, CE-marked, WHO Prequalified and USAID Approved products, such as HIV 1/2 STAT-PAK®, HIV 1/2 STAT-PAK® DIPSTICK, CE-marked STAT-VIEW® HIV 1/2, and HIV 1/2 SURE CHECK® Assays for blood are widely used in rapid HIV testing in the field. They require very small blood samples, as small as 2.5 µL, and have a high degree of sensitivity and specificity. The tests are also very easy to perform. HIV 1/2 STAT-PAK® DIPSTICK, priced for resource-limited markets, is the lowest cost product in our portfolio. Our products are manufactured in the U.S.

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Company data

Sales volume

10-49 Mio US $

Export content

max. 75%

Number of employees

100-499

Foundation

1985

Area of business

Diagnostics