Profile: Chembio Diagnostics Inc (CEMI.OQ)
16 Aug 2019
Chembio Diagnostics, Inc. (Chembio), incorporated on May 14, 1999, and its subsidiary, Chembio Diagnostic Systems, Inc., develop, manufacture, market and license rapid point-of-care diagnostic tests (POCTs) that detect infectious diseases. The Company's products include rapid tests for the detection of human immunodeficiency virus (HIV) 1/2 antibodies, and a multiplex rapid test for the detection of HIV and Syphilis antibodies. The HIV 1/2 rapid tests employ in-licensed and lateral flow technologies that are used with all blood matrices as samples, and are manufactured in a standard cassette format, a dipstick format, and a barrel format. The barrel format is distributed by a distributor in the United States and by Chembio and its designated distributors outside the United States. The Cassette format is distributed by Chembio and its designated distributors around the world. The Company's HIV 1/2 rapid antibody detection test incorporates the Dual Path Platform (DPP) POCT technology. The DPP HIV 1/2 Assay detects antibodies to HIV 1 and 2 in oral fluid samples, as well as in all blood matrices.
The Company's product pipeline, which includes a multiplex rapid test for earlier detection of HIV by detecting P-24 antigen, as well as antibodies, a test for Hepatitis-C, and a multiplex test that detects HIV and Syphilis specific antibodies, is based on the DPP technology. With the DPP and the lateral flow platform, the Company participates in the point-of-care market segment of the global in-vitro diagnostic market. POCTs, by providing prompt and early diagnosis, can reduce patient stays, lower overall costs, improve therapeutic interventions and improve patient outcomes. POCTs also prevents needless hospital admissions, simplify testing procedures, avoid delays from central lab batching and eliminate the need for return visits.
Lateral Flow Rapid HIV Tests
The Company's lateral flow rapid HIV antibody detection tests are qualitative yes/no tests for the detection of antibodies to HIV 1 and 2 with visually interpreted results available within approximately 20 minutes. StatSure Diagnostics, Inc. (SDS) owns interest in the rights to the SURE CHECK HIV 1/2 Assay that is subject to the existing marketing and distribution agreement with Alere, Inc. The Company's SURE CHECK HIV 1/2 Assay is sold in the United States as Clearview Complete. Outside the United States, Chembio markets the SURE CHECK HIV 1/2 Assay primarily through distributors. The SURE CHECK HIV 1/2 Assay is the United States Food and Drug Administration (FDA) approved, Clinical Laboratory Improvement Amendments (CLIA)-waived, European CE-marked, and has been pre-qualified by the World Health Organization (WHO). The Company's third lateral flow HIV test is the HIV 1/2 STAT PAK Dipstick.
DPP HIV 1/2 Assay
As in the case of the Company's lateral flow HIV tests, its DPP HIV 1/2 Assay is also a qualitative yes/no test for the detection of antibodies to HIV 1and 2, delivers visual results within approximately 20 minutes, is simple to use, has a shelf life of over 20months, and does not require refrigeration. This product is used with oral fluid samples, as well as with all blood matrices. This product also incorporates the Company's oral fluid collection and storage system that enables samples to be extracted in buffer solution before application to the test device, and also enables the extracted sample to be stored and retested or potentially tested for multiple conditions in future product applications.
DPP HIV-Syphilis Multiplex Test
DPP HIV-Syphilis Multiplex Test allows for the detection of antibodies to both HIV and Syphilis on a single test device within approximately 20 minutes. In certain global/public health settings, this product may provide a means of rapid detecting both markers in a single test procedure at the point of care as compared with performing separate rapid tests for each indication.
The Company competes with Orasure Technologies, Inc., Alere, Inc. and Trinity Biotech.
Chembio Diagnostics Inc
555 Wireless Blvd
HAUPPAUGE NY 11788-3966