Research & Development
Study suggests race adjustment unnecessary for alpha fetoprotein prenatal testing
Researchers recommend that a longstanding race-based adjustment to test-result values of alpha fetoprotein from a common prenatal screening should be discontinued.
February 6, 2023
Blood tests for concussion | Hidden Zika epidemic | Targeted prenatal genetic screening
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August 26, 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
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Netherlands researchers combine CRISPR, bioluminescence in proof-of-concept infectious disease test
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
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