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 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.
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 Genetics please visit /COVID19 or email the Fulgent team directly at .
About Fulgent Genetics
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. The company believes its current test menu, which includes approximately 18,000 single-gene tests and more than 850 pre-established, multi-gene, disease-specific panels, offers more genes for testing than its competitors in today’s market, which enables it to provide expansive options for test customization and clinically actionable results.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: anticipated timing, availability, demand for and effectiveness of the company’s testing services for COVID-19.
Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the company’s future performance, and they are based on management’s current assumptions, expectations and beliefs concerning future developments and their potential effect on the company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the market potential for, and the rate and degree of market adoption of, the company’s tests and genetic testing generally; the company’s ability to maintain the low internal costs of its business model; the company’s ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the company’s sale prices for and margins on its tests; risks related to volatility in the company’s results, which can fluctuate significantly from period to period; the company’s investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the company’s business and performance and enable it to manage any growth it may experience in future periods; the company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the company’s level of success in establishing and obtaining the intended benefits from partnerships, joint ventures or other relationships; the company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the company’s international operations; the company’s ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.
The forward-looking statements made in this press release speak only as of the date of this press release, and the company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.
The company’s reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2020 as filed with the SEC on May 6, 2020 and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the company’s website upon their filing with the Securities and Exchange Commission. These reports contain more information about the company, its business and the risks affecting its business.
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