Chembio Diagnostic Systems Inc.
Chembio Diagnostics is a leading point-of-care diagnostics company dedicated to developing, manufacturing, and commercializing rapid, easy-to-use, and reliable diagnostic solutions for infectious diseases. Their mission is to enable longer and healthier living through detection and monitoring of infectious diseases at the point of care, with a focus on diseases such as COVID-19, sexually transmitted infections, and tropical diseases. They aim to provide high-quality diagnostics worldwide, leveraging their innovative DPP technology to deliver fast and accurate results, often within 15 minutes, in decentralized and traditional testing settings.
Industries
Nr. of Employees
medium (51-250)
Chembio Diagnostic Systems Inc.
Patents
Method and apparatus for collecting and preparing biological samples for testing
US-11350913-B2
View DetailsRapid screening assay for qualitative detection of multiple febrile illnesses
US-10690667-B2
View Details
Method and apparatus for collecting and preparing biological samples for testing
US-11350913-B2
View DetailsRapid screening assay for qualitative detection of multiple febrile illnesses
US-10690667-B2
View DetailsProducts
Multiplex serologic point-of-care test for HIV and syphilis screening
Single-use, multiplex serologic rapid test detecting antibodies for HIV and syphilis from a small-volume blood sample with ~15-minute turnaround and compatibility with an optical reader for objective reporting.
Multiplex respiratory antigen test (SARS-CoV-2 and Influenza A/B)
Rapid immunoassay that simultaneously detects SARS-CoV-2 and influenza A/B antigens from a single nasal swab in ~15–20 minutes for decentralized testing, with instrument-free visual read or reader-assisted reporting.
Instrument-free rapid antigen test for SARS-CoV-2 (commercial distribution)
Rapid antigen test for SARS-CoV-2 detection from nasal swabs providing ~20-minute results suitable for symptomatic and serial asymptomatic screening, distributed through third-party partnerships.
Portable optical micro-reader analyzer for lateral-flow tests
Battery-operated optical analyzer that reads lateral-flow rapid test results and reports objective electronic outputs in seconds to reduce visual-interpretation variability and support decentralized workflows.
At-home lateral-flow SARS-CoV-2 antigen self-test (OTC)
Over-the-counter self-test format that provides SARS-CoV-2 antigen results from a nasal swab in ~20 minutes for consumer use, including distribution via retail and e-commerce channels.
HIV antibody self-test (fingerstick lateral-flow)
Single-use in vitro diagnostic self-test detecting HIV antibodies from a small fingerstick whole blood sample for consumer/OTC use where authorized.
Multiplex serologic point-of-care test for HIV and syphilis screening
Single-use, multiplex serologic rapid test detecting antibodies for HIV and syphilis from a small-volume blood sample with ~15-minute turnaround and compatibility with an optical reader for objective reporting.
Multiplex respiratory antigen test (SARS-CoV-2 and Influenza A/B)
Rapid immunoassay that simultaneously detects SARS-CoV-2 and influenza A/B antigens from a single nasal swab in ~15–20 minutes for decentralized testing, with instrument-free visual read or reader-assisted reporting.
Instrument-free rapid antigen test for SARS-CoV-2 (commercial distribution)
Rapid antigen test for SARS-CoV-2 detection from nasal swabs providing ~20-minute results suitable for symptomatic and serial asymptomatic screening, distributed through third-party partnerships.
Portable optical micro-reader analyzer for lateral-flow tests
Battery-operated optical analyzer that reads lateral-flow rapid test results and reports objective electronic outputs in seconds to reduce visual-interpretation variability and support decentralized workflows.
At-home lateral-flow SARS-CoV-2 antigen self-test (OTC)
Over-the-counter self-test format that provides SARS-CoV-2 antigen results from a nasal swab in ~20 minutes for consumer use, including distribution via retail and e-commerce channels.
HIV antibody self-test (fingerstick lateral-flow)
Single-use in vitro diagnostic self-test detecting HIV antibodies from a small fingerstick whole blood sample for consumer/OTC use where authorized.
Services
End-to-end design and execution of clinical validation and performance studies for point-of-care diagnostic assays to generate data for regulatory submissions.
Commercial distribution, in‑licensing and reseller arrangements for rapid diagnostics across clinical, public-health, retail/pharmacy and direct-to-consumer channels, including support for international distributor networks.
Establishment and management of third-party manufacturing agreements and regional production to support assay supply and scaling.
Program execution and administration for government-funded diagnostic development projects, including milestone management and support for regulatory interactions.
End-to-end design and execution of clinical validation and performance studies for point-of-care diagnostic assays to generate data for regulatory submissions.
Commercial distribution, in‑licensing and reseller arrangements for rapid diagnostics across clinical, public-health, retail/pharmacy and direct-to-consumer channels, including support for international distributor networks.
Establishment and management of third-party manufacturing agreements and regional production to support assay supply and scaling.
Program execution and administration for government-funded diagnostic development projects, including milestone management and support for regulatory interactions.
Expertise Areas
- Point-of-care diagnostic platform development
- Multiplex immunoassay design for low-volume and nasal-swab samples
- Clinical trial design and execution for diagnostics
- Regulatory strategy and submissions for in vitro diagnostics (EUA, 510(k), PMA, CLIA waiver)
Key Technologies
- Dual-path chromatographic lateral-flow multiplex architecture
- Lateral-flow rapid immunoassay formats (antigen and antibody)
- Optical micro-reader analyzers for lateral-flow tests
- Low-volume fingerstick sample processing (microliter-scale)
News & Updates
NCCHC Conference 2025
November 1-5, 2025, Baltimore, MD.
NACCHO 360, Booth #429
July 14-18, 2025, Anaheim, CA.
STI World Congress, Booth #E3
July 26-30, 2025, Montreal, Canada.
ADLM Clinical Lab Expo, Booth #4222
July 27-31, 2025, Chicago, IL.
FDA AWARDS BREAKTHROUGH DEVICE STATUS TO THE DPP® SYPHILIS TnT ASSAY
Chembio received FDA breakthrough device status for its DPP® Syphilis TnT assay, advancing rapid testing for sexually transmitted infections.
FDA Awards Breakthrough Device Status to the SURE CHECK® HIV Self-Test
Chembio's SURE CHECK® HIV Self-Test received FDA breakthrough device status, enhancing HIV self-testing options.
NCCHC Conference 2025
November 1-5, 2025, Baltimore, MD.
NACCHO 360, Booth #429
July 14-18, 2025, Anaheim, CA.
STI World Congress, Booth #E3
July 26-30, 2025, Montreal, Canada.
ADLM Clinical Lab Expo, Booth #4222
July 27-31, 2025, Chicago, IL.
FDA AWARDS BREAKTHROUGH DEVICE STATUS TO THE DPP® SYPHILIS TnT ASSAY
Chembio received FDA breakthrough device status for its DPP® Syphilis TnT assay, advancing rapid testing for sexually transmitted infections.
FDA Awards Breakthrough Device Status to the SURE CHECK® HIV Self-Test
Chembio's SURE CHECK® HIV Self-Test received FDA breakthrough device status, enhancing HIV self-testing options.