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The PCR-based test works with upper and lower respiratory specimens, including nasal swabs and sputum, and can be performed by high complexity labs.
The company's Linea COVID-19 assay kit is a high-sensitivity real-time, reverse-transcriptase PCR-based assay to detect target sequences of the SARS-CoV-2 Spike gene.
Takeda's financial contribution will enable the International Atomic Energy Agency to ramp up its initiative to supply RT-PCR tests to laboratories globally.
The expansion increases the number of PCR instruments and types of reagents and consumables labs can use to run the Applied Biosystems TaqPath COVID-19 Combo Kit.
The federal agency approved the use of the Zymo Research SARS-CoV-2 kit with both upper respiratory and lower respiratory specimens.
The firm said it can produce enough viral RNA extraction reagents to support more than 7 million real-time PCR tests per month for detecting SARS-CoV-2.
The company had received CE marking for the test in April, allowing for its use as a clinical diagnostic test in Europe.
Fulgent saw a 75 percent increase year over year in billable tests, leading to revenues of $7.8 million. It also withdrew its 2020 full-year revenue guidance.
The rapid automated RT-PCR test detects SARS-CoV-2 from nasopharyngeal, oropharyngeal, or nasal swab specimens and runs on NeuMoDx's Molecular Systems.
Replacing nasopharyngeal swabs with saliva samples or nasal swabs could increase throughput and convenience, as well as relieve reagent and equipment shortages.