Chembio Diagnostics Awarded $12.7 Million by BARDA for Development of Rapid DPP Respiratory Antigen Panel and 510(k) Submission of the Rapid DPP SARS-CoV-2 Antigen Test System - Seite 2
“We are honored to again partner with BARDA and appreciate their support as we endeavor on the shared mission to expand and decentralize COVID-19 testing,” stated Richard Eberly, Chembio’s President and Chief Executive Officer. “The DPP technology is highly versatile, and these new product and regulatory objectives illustrate our commitment to offering virus detection for diagnosis at the point-of-care. We believe rapid, point-of-care tests can improve clinical outcomes and play a major role in combating this ongoing pandemic, especially during the upcoming flu season.”
About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through
advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain
applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for
decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of
the types of human error that can be experienced in the visual interpretations required by many rapid tests.
Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.
All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.
Lesen Sie auch
About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease.
Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and
through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.