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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.
SARS-CoV-2 might have resulted from recombination between pangolin and bat coronaviruses, with pangolins serving as an intermediate host.
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.
The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.
Novacyt has initially committed to supply 288,000 tests per week to the DHSC, and it has an option to expand the agreement.
The FDA and CDC call for a pause in administering Johnson & Johnson's SARS-CoV-2 vaccine while reports of rare blood clots are looked into, reports the Wall Street Journal.
According to the Associated Press, a Swiss program aims to shepherd long-term science projects and diplomacy.
CNN reports that two new studies suggest the B.1.1.7 SARS-CoV-2 variant may be more transmissible, but may not lead to more severe disease.
In PNAS this week: analysis of pathway affecting acute kidney injury, parental-specific allelic expression in horse placenta, and more.