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During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.
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.
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.
Nobel laureates and scientific societies urge NIH and the Department of Health and Human Services to revisit the recent decision to end funding for a coronavirus grant.
Bloomberg reports that BGI's SARS-CoV-2 testing sites in the Middle East have raised concerns among US officials.
A new Pew Research Center poll finds confidence in medical researchers has grown among US adults since the start of the coronavirus pandemic.
In Science this week: machine learning algorithm for faster Mendelian disorder diagnoses, gene linked to safe response to nitrogen-containing bisphosphonates, and more.