Fulgent Genetics, a provider of comprehensive genetic testing solutions, today said that its subsidiary, Fulgent Therapeutics, LLC, 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, by 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 via its BSL-2, CLIA-certified lab in Temple City, California.
Also, 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 got an EUA by the FDA only for the detection.
Fulgent Genetics is a growing technology company with an initial focus on offering comprehensive genetic testing to provide physicians with clinically actionable diagnostic information they can use to improve the quality of patient care. The company has developed a proprietary technology platform that integrates sophisticated data comparison and suppression algorithms, adaptive learning software, advanced genetic diagnostics tools and integrated laboratory processes.
This platform allows the company to offer a broad and flexible test menu and continually expand and improve its proprietary genetic reference library, while maintaining accessible pricing, high accuracy and competitive turnaround times.