Chembio Diagnostic Systems Inc.
Developer and manufacturer of point-of-care rapid diagnostic tests for infectious diseases. Designs multiplex lateral-flow and dual-path rapid immunoassays and portable readers for decentralized and home-use testing, performs clinical validation studies and regulatory submissions (EUA/510(k)/PMA, CLIA waiver, CE, Breakthrough Device interactions), operates manufacturing facilities and manages international contract manufacturing relationships (including ISO 13485 and WHO prequalification-qualified facilities), executes government- and foundation-funded development programs, and engages in direct-to-consumer and channel distribution.
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 HIV–syphilis rapid serology test (CLIA-waived point-of-care)
Single-use multiplex serologic test designed to detect antibodies to HIV and Treponema pallidum from fingerstick or venous blood with integrated procedural control and short time-to-result.
Zika IgM rapid serology test (510(k)-cleared)
Rapid serology test for Zika IgM antibodies compatible with fingerstick whole blood, venous whole blood, plasma or serum with a small sample volume and ~15-minute time-to-result.
SARS‑CoV‑2 IgM/IgG serology rapid test (reader-compatible)
Serology rapid test that differentiates IgM and IgG antibodies from fingerstick, venous blood, serum or plasma with ~15-minute time-to-result and optional reader-based outputs.
Multi-pathogen respiratory antigen panel (reader-capable)
Rapid antigen test intended to detect SARS-CoV-2, influenza A and influenza B antigens from a single nasal swab with reader-read capability and approximately 20-minute time-to-result.
HIV self-test for over-the-counter / home use (Breakthrough Device designated)
Single-use immunoassay self-test designed for lay users to detect antibodies to HIV using a small fingerstick blood sample; received Breakthrough Device designation from the U.S. FDA to support expedited regulatory interactions.
Combined treponemal / non-treponemal syphilis assay (Breakthrough Device designated)
Rapid assay designed to detect both treponemal and non-treponemal antibody responses in a single test using fingerstick or venous blood with rapid results and reader support; received Breakthrough Device designation to support regulatory pathway.
Multiplex HIV–syphilis rapid serology test (CLIA-waived point-of-care)
Single-use multiplex serologic test designed to detect antibodies to HIV and Treponema pallidum from fingerstick or venous blood with integrated procedural control and short time-to-result.
Zika IgM rapid serology test (510(k)-cleared)
Rapid serology test for Zika IgM antibodies compatible with fingerstick whole blood, venous whole blood, plasma or serum with a small sample volume and ~15-minute time-to-result.
SARS‑CoV‑2 IgM/IgG serology rapid test (reader-compatible)
Serology rapid test that differentiates IgM and IgG antibodies from fingerstick, venous blood, serum or plasma with ~15-minute time-to-result and optional reader-based outputs.
Multi-pathogen respiratory antigen panel (reader-capable)
Rapid antigen test intended to detect SARS-CoV-2, influenza A and influenza B antigens from a single nasal swab with reader-read capability and approximately 20-minute time-to-result.
HIV self-test for over-the-counter / home use (Breakthrough Device designated)
Single-use immunoassay self-test designed for lay users to detect antibodies to HIV using a small fingerstick blood sample; received Breakthrough Device designation from the U.S. FDA to support expedited regulatory interactions.
Combined treponemal / non-treponemal syphilis assay (Breakthrough Device designated)
Rapid assay designed to detect both treponemal and non-treponemal antibody responses in a single test using fingerstick or venous blood with rapid results and reader support; received Breakthrough Device designation to support regulatory pathway.
Services
Project-based development, optimization and clinical validation of rapid diagnostic assays under government contracts and philanthropic grants.
On-site manufacture of rapid diagnostic assays in U.S. facilities and coordination of international contract manufacturing arrangements with qualified partners.
Commercial distribution and fulfillment of in-house and third-party rapid antigen and serology tests through distributor channels and direct-to-consumer / OTC channels.
Support for regulatory filings, clinical study design and interactions with regulatory agencies, including programs that enable expedited review.
Project-based development, optimization and clinical validation of rapid diagnostic assays under government contracts and philanthropic grants.
On-site manufacture of rapid diagnostic assays in U.S. facilities and coordination of international contract manufacturing arrangements with qualified partners.
Commercial distribution and fulfillment of in-house and third-party rapid antigen and serology tests through distributor channels and direct-to-consumer / OTC channels.
Support for regulatory filings, clinical study design and interactions with regulatory agencies, including programs that enable expedited review.
Expertise Areas
- Point-of-care diagnostics
- Multiplex rapid assay development
- Serology (multi-class antibody) assay development
- Small-volume capillary blood testing workflows
Key Technologies
- Multiplex lateral-flow / dual-path immunoassays
- Portable optical / micro-reader devices for objective readout
- Small-volume capillary blood assays (≈10 µL)
- Multi-class antibody detection (IgM/IgG/IgA) assays
News & Updates
Chembio became a wholly-owned indirect subsidiary of Biosynex following completion of a tender offer and merger; transaction closing recorded on April 27, 2023.
Awarded a $1.5 million grant from the Bill & Melinda Gates Foundation to develop a rapid point-of-care diagnostic for congenital syphilis that separately detects treponemal and non-treponemal IgM and IgA from small blood volumes.
FDA granted Breakthrough Device status for a rapid HIV self-test intended for over-the-counter/home use to support expedited regulatory interactions.
FDA granted Breakthrough Device designation to a combined treponemal/non-treponemal syphilis rapid assay intended to aid point-of-care diagnosis of active syphilis.
Awarded a grant to develop a rapid lateral-flow test to detect biomarkers (for example sFlt-1) to assist triage of pregnant women with symptoms of preeclampsia using a small blood volume and reader- or visual-read options.
Awarded a BARDA contract to support development of a point-of-care COVID-19 antigen system and an EUA submission.
Chembio became a wholly-owned indirect subsidiary of Biosynex following completion of a tender offer and merger; transaction closing recorded on April 27, 2023.
Awarded a $1.5 million grant from the Bill & Melinda Gates Foundation to develop a rapid point-of-care diagnostic for congenital syphilis that separately detects treponemal and non-treponemal IgM and IgA from small blood volumes.
FDA granted Breakthrough Device status for a rapid HIV self-test intended for over-the-counter/home use to support expedited regulatory interactions.
FDA granted Breakthrough Device designation to a combined treponemal/non-treponemal syphilis rapid assay intended to aid point-of-care diagnosis of active syphilis.
Awarded a grant to develop a rapid lateral-flow test to detect biomarkers (for example sFlt-1) to assist triage of pregnant women with symptoms of preeclampsia using a small blood volume and reader- or visual-read options.
Awarded a BARDA contract to support development of a point-of-care COVID-19 antigen system and an EUA submission.