BARDA, Chembio Diagnostics Partnership Results in FDA-Cleared Diagnostic Test for Zika
Test becomes 55th FDA approval supported by BARDA, further improving U.S. emergency preparedness and response capability
Chembio’s DPP® Zika IgM System, a diagnostic test for Zika, became the fifty-fifth U.S. Food and Drug Administration clearance, approval or licensure supported by BARDA. BARDA’s advanced research and development program supported the diagnostic’s development over the past three years, and on June 3, 2020, the test received FDA authorization for marketing.
This diagnostic test is designed to detect Zika virus specific Immunoglobulin M, or IgM, antibodies produced by the body’s immune response to the virus.
The Chembio DPP® Zika IgM System, which includes the DPP® Zika Test Device and the DPP® Micro Reader, can use fingerstick whole blood specimens to provide a result after just 15 minutes. The test is intended for use only in patients meeting the Zika virus clinical criteria designated by the Centers for Disease Control and Prevention (CDC) and/or CDC’s Zika virus epidemiological criteria. The test is most useful eight days after the onset of symptoms and up to 12 weeks following initial infection.
The Zika virus is a mosquito-borne flavivirus that can cause fever, rash, conjunctivitis, muscle and joint pain, malaise or headache. Although most people do not develop symptoms, a Zika virus infection during pregnancy can cause infants to be born with microcephaly and other congenital malformations. Zika diagnostic test results can help inform healthcare providers when making recommendations about their patients’ care, particularly for prenatal care of pregnant patients.
About Chembio Diagnostics, Inc.:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases. 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.
More information about Chembio Diagnostics, Inc. can be found at www.chembio.com.