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Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus that Causes COVID-19
TEMPLE CITY, Calif., May 18, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the “company”), a provider of comprehensive
About this update from Fulgent Genetics, Inc.
[{"type":"text","content":"TEMPLE CITY, Calif., May 18, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the “company”), a provider of comprehensive genetic testing solutions, today announced that its subsidiary, Fulgent Therapeutics, LLC, 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, 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 BSL-2, CLIA-certified lab in Temple City, California.\n 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 EUA enables the company to process these samples at its lab in Temple City. “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.” Fulgent Genetics’ 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. Amplification of both targets will signify a positive result; amplification of one of two targets will signify an indeterminate (inconclusive) result; and no amplification of either target, but amplification of internal control, will signify a negative result. Inconclusive results will require a new sample for testing. Fulgent Genetics’ RT-PCR test for COVID-19 has been granted an EUA by the FDA only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. For more information about COVID-19 testing options from Fulgent ...