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The latest regulatory news and FDA approvals.
Laboratorio Clinico Toledo's test detects SARS-CoV-2 nucleic acid, while Assure Tech's test is designed to detect antibodies against the virus.
The firm said its coronavirus assay targets the nucleocapsid and envelope virus genes and is compatible with most RNA extraction methods and qPCR instruments.
The combination flu and RSV assay can be used alone or in combination with the company's Simplexa COVID-19 Direct assay for SARS-CoV-2 infection.
The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.
The test can help diagnose spinal muscular atrophy and identify carriers without symptoms who may be at risk of passing the disease to their children.
The US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.
The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.
Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.
In Nucleic Acids Research this week: algorithm to determine molecular sequence types and other microbial features, computational method to uncover R-loop structures, and more.