The U.S. Food and Drug Administration (FDA) cleared InBios International's blood test on May 23 for detecting immunoglobulin antibodies to Zika virus -- in a first for the U.S. market -- and is considering revoking clearance for companies that have emergency use authorizations (EUAs) for similar tests.
InBios' ZIKV Detect 2.0 IgM Capture ELISA test was cleared through the agency's de novo premarket review pathway for low- to moderate-risk devices of a new type. In the future, similar tests will be reviewed through the 510(k) route, based on evidence of substantial equivalence.
The ZIKV Detect product is the first diagnostic "allowed to be marketed" in the U.S., as up to now tests have been made available through an EUA, the agency noted in a statement. The FDA explained that it needed to make tests available quickly, while working to get products cleared through standard procedures.
Four tests that are similar may now lose their EUA, while another 14 diagnostics will stay on the market, the agency said. The following four tests may have their emergency use authorizations revoked:
- Liaison XL Zika Capture IgM Assay II (DiaSorin)
- DPP Zika IgM Assay System (Chembio Diagnostic Systems)
- CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay
- Advia Centaur Zika test (Siemens Healthcare Diagnostics)
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The FDA clearance of the ZIKV Detect test covers use in patients with signs and symptoms of Zika virus and/or those who have been in areas where they were exposed to Zika virus. The filing was supported by a study of 807 test samples and analytical studies supporting the product's safety and effectiveness.
The clearance is welcome news for laboratories in states that have handled Zika virus cases in the past and for manufacturers of in vitro diagnostics, commented Bruce Carlson, publisher of market research company Kalorama Information, a sister company of LabPulse.com.
"Zika tests have arrived in a sense," Carlson said. "Tests have made it from emergency ad hoc status, and we are now seeing Zika joining infectious diseases for which there is immunoassay testing using the standard regulatory pathway."
Clearance comes at a time when the Zika virus, which is spread by the Aedes species mosquito and can cause disabling neurological conditions and birth defects, is much less of a threat. According to the U.S. Centers for Disease Control and Prevention (CDC), limited local mosquito-borne Zika virus transmission was reported in 2016, and no cases of mosquito-borne virus transmission were reported in the continental U.S., the FDA noted in its statement.
According to the CDC website, as of May 1 in the U.S. states and territories, only one case of Zika virus was reported in 2019 for someone who had traveled to an affected area. That compares with 72 cases reported in U.S. states (with the highest number in California) in 2018, all in people who contracted the virus while traveling to an affected area. In 2018, 148 cases of Zika virus had been reported in U.S. territories, almost all of which were thought to be caused by local mosquito-borne transmission.