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In a guidance, the agency described expanded policies that will enable manufacturers, local labs, and others to quickly deploy coronavirus testing.
Under the NYSDOH's approach, labs need to provide validation data within 15 days of starting to test instead of having to pursue an EUA with the FDA.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The company's +RNAinsight test, a combined DNA and RNA genetic test for hereditary cancer syndromes, was launched in October.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.
The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
MSK-ACCESS sequences 129 cancer-associated genes selected from the MSK-IMPACT assay and is designed to detect gene alterations in cfDNA specimen.
The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.
President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.
A study of Great Danes homes in on a genomic region linked to fearfulness.
CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.
In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.