Vela Diagnostics Lau...
Multiplex PCR Amplid...
30th August 2016 Content supplied by: Chembio Diagnostics, Inc.
Chembio Awarded US Government Contract to Develop POC Zika Tests
Chembio Diagnostics, Inc. has been awarded a contract for up to $13.2 million in total funding from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) for the development and commercialization of the Company's rapid POC Zika test and Zika-related products.
The award includes an initial commitment of $5.9 million allocated specifically to the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, as well as an option for an additional $7.3 million to fund the development, clinical trial and regulatory submissions related to the Company's DPP® Zika/Chikungunya/Dengue IgM/IgG Combination Assay.
John Sperzel, Chembio's Chief Executive Officer, commented, "We are very happy to receive this BARDA contract as it will allow the Company to further develop the DPP® Zika IgM/IgG Assays, complete key clinical trials, and complete important U.S. regulatory submissions. Given the limitations of laboratory-based Zika tests, we believe Chembio's POC DPP® Zika IgM/IgG Assays will become essential tools in the battle against the Zika virus, which is likely to endanger millions of people, in both the U.S. and abroad in the coming years, especially pregnant women."
The Company believes currently available genetic tests for the Zika virus have limited utility as they are accurate only during a narrow window of time between initial Zika virus exposure and the patient's development of detectable antibodies to the virus, a process known as seroconversion. Following seroconversion, antibody tests are recommended to accurately identify Zika virus infections. The DPP® Zika IgM/IgG Assay will provide timely results, during the patient consultation. The DPP® Zika System, which includes the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, detects both IgM and IgG antibodies, uses a 10uL fingerstick blood sample and provides quantitative results in 15 minutes.
The DPP® Zika/Chikungunya/Dengue IgM/IgG Combination Assay simultaneously detects IgM and IgG antibodies for Zika, Dengue and Chikungunya, uses a 10uL fingerstick blood sample and provides quantitative results in 15 minutes.
Date Published: 30th August 2016
Source article link: View
Vela Diagnostics Launches CE-IVD Zika
Multiplex PCR Amplidiag® Detects Main