Research & Development
FDA offers reference panel to help validate COVID-19 diagnostics
The reference panel is a tool for evaluating whether a diagnostic test is accurate in the detection of SARS-CoV-2 RNA. It will be available to commercial and laboratory developers pursuing clearance through the agency's emergency use authorization (EUA) program, the agency said in a May 27 announcement. Developers with well-characterized reagents will now be able to compare different tests under the same conditions, the agency said. Reference tools have been helpful for evaluating diagnostics for other infectious diseases in the past, such as the Zika virus.
May 27, 2020
Roche launches Zika blood screening test in Europe
The test screens for the Zika virus in human plasma and is designed for use with the company's cobas 6800/8800 systems. Roche noted that it has been marketing the Zika test for screening blood donations in the U.S. and U.S. territories since 2017, in consultation with the Food and Drug Administration.
December 16, 2019
Research sheds light on Zika virus, microcephaly connection
The researchers noted the presence of brain abnormalities in a patient cohort at Baylor-Hopkins Center for Mendelian Genomics similar to those seen in newborns infected by the Zika virus in utero. Studying this cohort, the group discovered that the gene ANKLE2 was associated with microcephaly. Because the Zika virus is known to cause newborn microcephaly, the team posited and examined a potential connection between the ANKLE2 gene and the virus.
November 24, 2019
Genomic analysis suggests Zika outbreaks are underreported
A large disease outbreak in Cuba in 2017 was caused by Zika, but it went unreported at the time, according to an analysis of travel patterns, mosquito modeling, and sequenced virus genomes taken from infected travelers, according to Yale School of Public Health epidemiologist Nathan Grubaugh, PhD, and colleagues (Cell, Vol. 178, pp. 1-15).
August 22, 2019
FDA's green light for InBios product signals arrival of Zika virus 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.
May 23, 2019
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