FDA has granted an emergency use authorization (EUA) to Fulgent Therapeutics, Temple City, Calif, a subsidiary of Fulgent Genetics, for its reverse transcription polymerase chain reaction (RT-PCR) test for the detection of SARS-CoV-2, the virus that causes covid-19, using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs). The company is offering end-to-end processing, analysis, and reporting for its covid-19 tests through its CLIA-certified BSL-2 lab.
The EUA allows for the test to be used with nasal swab specimens that are either self-collected by patients at home or in a healthcare setting, using an authorized at-home collection kit offered by a third party, when determined to be appropriate by a healthcare provider. Fulgent’s EUA permits the company to process patient samples at its lab.
“I am proud of the work our team has done to receive this EUA from FDA for our RT-PCR test for covid-19,” says 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.”
Fulgent Genetics’ primer and probe sets are designed to detect RNA from SARS-CoV-2 in specimens from patients who meet covid-19 clinical criteria from the Centers for Disease Control and Prevention. Primer and probe set sequences are based on CDC-recommended guidelines that identify two known distinct regions within the SARS-CoV-2 genome. Amplification of both targets signifies a positive result; amplification of one of two targets signifies an indeterminate (inconclusive) result; no amplification of either target, but amplification of the internal control, signifies a negative result. Inconclusive results require a new sample for testing.
For more information, visit Fulgent Genetics.