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The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.’s Gene-RADAR® Zika Virus Test.
The Gene-RADAR® Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum.
The test should be used on serum samples collected from individuals meeting the US Centers for Disease Control and Prevention’s (CDC) criteria for Zika virus testing.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
The Gene-RADAR® Zika Virus Test is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
The Gene-RADAR® Zika Virus Test should be performed according to the CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).
According to the CDC, Zika virus RNA has been detected in serum up to 13 days post-symptom onset in non-pregnant patients, up to 62 days post-symptom onset in pregnant patients, and up to 53 days after the last known possible exposure in an asymptomatic pregnant woman.
About the EUA
The EUA does not mean the Gene-RADAR® Zika Virus Test is FDA cleared or approved.
An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The EUA for the Gene-RADAR® Zika Virus Test means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
More information on the Gene-RADAR® Zika Virus Test and other Zika tests granted EUAs can be found on the FDA’s EUA page. 
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.’s Gene-RADAR® Zika Virus Test.
The Gene-RADAR® Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum.
The test should be used on serum samples collected from individuals meeting the US Centers for Disease Control and Prevention’s (CDC) criteria for Zika virus testing.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
The Gene-RADAR® Zika Virus Test is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
The Gene-RADAR® Zika Virus Test should be performed according to the CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).
According to the CDC, Zika virus RNA has been detected in serum up to 13 days post-symptom onset in non-pregnant patients, up to 62 days post-symptom onset in pregnant patients, and up to 53 days after the last known possible exposure in an asymptomatic pregnant woman.
About the EUA
The EUA does not mean the Gene-RADAR® Zika Virus Test is FDA cleared or approved.
An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The EUA for the Gene-RADAR® Zika Virus Test means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
More information on the Gene-RADAR® Zika Virus Test and other Zika tests granted EUAs can be found on the FDA’s EUA page.
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.’s Gene-RADAR® Zika Virus Test.
The Gene-RADAR® Zika Virus Test is authorized for the qualitative detection of RNA from Zika virus in human serum.
The test should be used on serum samples collected from individuals meeting the US Centers for Disease Control and Prevention’s (CDC) criteria for Zika virus testing.
This includes clinical criteria—such as a history of clinical signs and symptoms associated with Zika virus infection—and/or epidemiological criteria—such as a history of residence in or travel to a geographic region with active Zika transmission.
The Gene-RADAR® Zika Virus Test is intended for use in US laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests, or by similarly qualified non-US laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb-3).
The Gene-RADAR® Zika Virus Test should be performed according to the CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).
According to the CDC, Zika virus RNA has been detected in serum up to 13 days post-symptom onset in non-pregnant patients, up to 62 days post-symptom onset in pregnant patients, and up to 53 days after the last known possible exposure in an asymptomatic pregnant woman.
About the EUA
The EUA does not mean the Gene-RADAR® Zika Virus Test is FDA cleared or approved.
An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
The EUA for the Gene-RADAR® Zika Virus Test means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
More information on the Gene-RADAR® Zika Virus Test and other Zika tests granted EUAs can be found on the FDA’s EUA page.