NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Chembio Diagnostic System, Inc.

Business Name:
Chembio Diagnostic System, Inc.
Business Genre:
Business Description:

Chembio specializes in development, manufacture and commercialization of diagnostic solutions. Their focus is to develop products that provide ease of use, and rapid and accurate results at the point-of-care (POC) [2-3].

City:
Medford
State:
NY
Country:
USA
Data/Evidence of Effectiveness:
Extensive testing from populations in New York and East Asia were performmed. Positive Agreement, Negative agreement, corss reactivity, plasma vs. fingerstick data are all presented in company product insert available on request- file:///Users/shriya_s/Downloads/DPPCovid19TestPI-EUA.pdf
Complimentary Products Needed to Perform Test:
Must purchase DPP control IgM/ IgG pack and DPP Microreader with the test kit [1]
Setting of Care:
Point of care [1, 3]
Current Status / Clinical Development Stage / Expected Milestones:
FDA EUA authorized [4]. Company signed a multi-year, non‑exclusive agreement with Thermo Fisher Scientific’s healthcare channel, to distribute Chembio’s DPP COVID-19 System in the United States [2].
Funding & Ownership :
Private. Amount undisclosed [3].
Business Model:
Company strengths are product development, manufacturing and commercialization expertise. Chembio has products on the market in over 40 countries primarily for the rapid and early detection of HIV and syphilis. Chembio is involved in multiple collaborations to address several diseases [2]. They cater to the point of care market by developing quality rapid tests [3].
IP:
Yes- technology uses the company’s patented Dual Path Platform (DPP) [1-3].
History & Origins :
Company was founded in 1986 [3]. They develop, manufacture, licenses and markets proprietary rapid diagnostic tests in the point-of-care testing market. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP®. 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 13.485 [2-3].
Date EUA Issued:
4/14/2020 [4]
Sources:
1. http://chembio.com/dpp-covid-19-igm-igg-system/ 2. http://chembio.com/about-us/ 3. https://www.crunchbase.com/organization/chembio-diagnostic-systems-inc#section-overview 4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Organization:
“Richard L. Eberly- President, Chief Executive Officer A. Goldman, CPA- Executive Vice President, Chief Financial Officer Javan Esfandiari- Executive Vice President, Chief Science and Technology Officer Robert Passas Ph.D.- Senior Vice President, Chief Commercial Officer Tom Ippolito- Vice President, Quality and Regulatory Affairs Paul Lambotte- Vice President, Research and Development Paul J. Angelico- Vice President, Global Operation”
No. Tests Per Day:
serology strip >2000/ day
Time to Result:
15 minutes [1]
Test Sample Type:
Fingerstick whole blood/ venous whole blood/ serum/ plasma [1]
Technology Overview:
“Rapid test for the detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in capillary “fingerstick” whole blood, venous whole blood, serum and plasma samples. Allows simultaneous and separate detection of IgM and IgG antibodies using their readers. Readers are simple to use, handheld, and portable. The test requires small sample size- 10 μL and results in 15 minutes. Can store at room temperature (2°C to 30°C; 36°F to 86°F) [1]. “
Testing Type:
Serology IgM/IgG Rapid Test for Fingerstick Blood [1]
Test Category:
SEROLOGY
Test Name:
DPP® COVID-19 IgM/IgG System [1]
Clinical Application & Need:
Detect and distinguish patients with IgM vs. IgG antibodies [1].
Age of Company:
1986 [3]

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