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Fulgent Receives FDA Emergency Use Authorization for SARS-CoV-2 RT-PCR Test

By LabMedica International staff writers
Posted on 26 May 2020
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Image: Fulgent`s Specimen Collection Kit (Photo courtesy of Fulgent Genetics, Inc.)
Image: Fulgent`s Specimen Collection Kit (Photo courtesy of Fulgent Genetics, Inc.)
Fulgent Genetics, Inc. (Temple City, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its RT-PCR test for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs).

In addition, the EUA allows for the test to be used with nasal swab specimens which are either self-collected by patients at home or in a health care setting using an authorized at-home collection kit offered by a third party, when determined to be appropriate by a health care provider. Fulgent’s RT-PCR test for the coronavirus is a reverse transcription polymerase chain reaction test to detect SARS-CoV-2. The SARS-CoV-2 primer and probe sets are designed to detect RNA from 2019-nCoV in specimens from patients who meet CDC 2019-nCoV clinical criteria. Primer and probe set sequences are based on CDC recommended guidelines that identify two known distinct regions within the SARS-CoV-2 genome.

“I am proud of the work our team has done to receive this EUA from the FDA for our RT-PCR test for COVID-19,” said Ming Hsieh, Chairman and Chief Executive Officer of Fulgent Genetics. “We look forward to further contributing to the fight against this global pandemic by increasing the availability of reliable testing options for COVID-19.”

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Fulgent Genetics, Inc.

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