Orig3n Receives FDA Emergency Use Authorization (EUA) For Coronavirus 2019 Test
BOSTON, April 13, 2020 /PRNewswire/ -- Orig3n, Inc., a Boston-based company pioneering the future of wellness and health through genetics and biotechnology, is offering the Orig3n 2019 Novel Coronavirus (COVID-19) Test under an Emergency Use Authorization (EUA) from FDA, to authorized healthcare providers and institutions nationwide. The test detects the presence of nucleic acid from the virus that causes COVID-19, and is for use with patients suspected of having contracted COVID-19 (subject to current guidance for administration of tests in order to evaluate infection).
"In 2019 alone, Orig3n performed over 300,000 genomic tests for consumers from all over the country, demonstrating our considerable technology, automation and logistics capacity," said Robin Y. Smith, President and CEO of Orig3n. "With the emergence of the COVID-19 crisis, we have decided to focus some of our capacity on meeting the urgent, clinical needs of our country. On April 10, Orig3n's COVID-19 test was formally authorized pursuant to an Emergency Use Authorization from FDA, demonstrating our ability to meet the FDA's rigorous standards for sensitivity and specificity in detecting the presence of nucleic acid from the virus that causes COVID-19. We are proud to help by offering this test and will work with the FDA and other government partners to offer additional testing that addresses the nation's needs, including serology testing, as validated reagents become available."
Orig3n's test is a validated, real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab specimens from individuals suspected of COVID-19.
"Orig3n has developed a robust business in the consumer genomics field, partnering with leading companies to bring the power of genomics to daily life needs in nutrition, wellness, and beauty," said Mr. Smith. "With the launch of the COVID-19 test, Orig3n embarks on a next phase of growth by entering the clinical diagnostics field. On the foundation of automation, software, and logistics technologies, we believe that we will be able to evaluate many thousands of COVID-19 samples each day in our CLIA-certified, high complexity laboratory. We will continue to stay closely involved in the ongoing response to this pandemic and will endeavor to expand our testing capacity and testing platforms to help address the urgent needs of our country."
Test results will be available in 24-36 hours from receipt of specimens in Orig3n's Boston laboratory. For more information about the test, please visit https://orig3n.com/covid19.
"As COVID-19 continues to spread throughout the United States, having high-quality, reliable, scalable laboratory tests available is a critically important part of our nation's response," said Gordon Siek, PhD, CLIA Laboratory Director for Orig3n. "Identifying patients who may be infected is imperative to allowing healthcare providers to deliver appropriate care in light of significant shortages of treatment resources, and to help contain the spread of COVID-19."
The Orig3n 2019 Novel Coronavirus (COVID-19) Test is made available pursuant to the "Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff", which was issued by FDA on February 29, 2020 (as subsequently modified). The EUA will be effective until the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 is terminated. More information regarding FDA's authorization can be found FDA's website at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd%5C).
More information about Orig3n's response to COVID-19 is available at https://orig3n.com/covid19.
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SOURCE Orig3n Inc.