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The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.
NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.
The company plans to take a tiered approach to assay development, targeting its first test to 10 viruses commonly detected in transplant patients.
The test will leverage next-generation sequencing to sequence PCR amplicons of the UL54 and UL97 genes in which drug resistance with CMV has been associated.
In PNAS this week: methanogen ancestry, within-host human cytomegalovirus genetic diversity, and more.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
The company is using its informatics services business to inform internal diagnostic research and development efforts.
The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.
The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.