RT-PCR

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.

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.