Tag Archives: Chembio Diagnostics

December 2018—Chembio Diagnostics announced FDA emergency use authorization for its DPP Ebola Antigen System for use with human capillary fingerstick whole blood, EDTA venous whole blood, and EDTA plasma. The test detects viral antigens and provides qualitative results in 15 to 20 minutes when used with the handheld, battery-operated DPP Micro Reader.

December 2017—Chembio Diagnostics received FDA emergency use authorization for its DPP Zika System. The system, for use in high- and moderate-complexity CLIA-certified laboratories, provides results in 15­–20 minutes from 10 µL of blood and includes the DPP Zika IgM Assay and DPP Micro Reader.

March 2016—Chembio Diagnostics will begin selling its Sure Check HIV 1/2 Assay in the U.S. market on June 1. The product is currently distributed in the United States by Alere under Alere’s Clearview Complete brand, and Chembio has notified Alere that it will not renew or extend the distribution agreement when it terminates on May 31.

February 2014—Chembio Diagnostics has entered a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the Centers for Disease Control and Prevention for a multiplex POC influenza immunity test using Chembio’s patented Dual Path Platform technology.

January 2015—Chembio Diagnostics announced it has entered into an exclusive agreement with Integrated BioTherapeutics, a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases. Under the terms of the agreement, Chembio will combine its patented Dual Path Platform technology with IBT’s proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness. Chembio will have exclusive rights to any POC product developed through this agreement.

June 2014—Chembio will begin marketing and selling the FDA-approved and CLIA-waived Chembio HIV 1/2 STAT-PAK assay in the U.S. market.

January 2014—Chembio Diagnostics received its first purchase order for its DPP HIV-Syphilis Assay from its distributor in Mexico. The DPP HIV-Syphilis Assay is based on the company’s patented Dual Path Platform (DPP), a point-of-care testing platform that is suited to multiplexing and that adds a syphilis biomarker to the company’s FDA-approved DPP HIV 1/2 test. The addition of this marker has resulted in a fingerstick whole blood test that can help reduce the transmission of HIV and syphilis from mother to child.

Chembio Diagnostics’ Sure Check HIV 1/2 assay has received CE Mark approval. The assay is now cleared for commercialization within the EU for rapid point-of-care detection of HIV. The product is FDA approved and distributed in the United States as Clearview Complete HIV 1/2 by Alere.

Chembio Diagnostics has commenced CLIA waiver studies for its DPP HIV 1/2 assay. In December 2012, Chembio received FDA approval for its DPP HIV 1/2 assay, which detects antibodies to HIV 1/2 in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples.

Chembio Diagnostics reported that data from a study evaluating the sensitivity and specificity of the company’s point-of-care Dual Path Platform (DPP) rapid test for syphilis was recently published online in Clinical Infectious Diseases.

Chembio Diagnostics has received FDA approval to market its point-of-care Dual Path Platform (DPP) HIV 1/2 assay for the rapid detection of HIV-1/2 antibodies in oral fluid or blood samples.