BOSTON, May 12, 2020 /PRNewswire/ -- Orig3n, Inc., a Boston-based company pioneering the future of wellness and health through genetics and biotechnology, has announced a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.
Orig3n 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).
"While our nursing homes, employers, cities and towns are in great need of testing, they face the greatest challenges in coordinating multiple suppliers and service providers to provide testing on the scale that is needed," said Robin Y. Smith, President and CEO of Orig3n. "Orig3n offers a single, seamless, end-to-end solution that incorporates specimen collection swabs, healthcare providers to collect specimens, logistics of transporting the specimens back to the laboratory, and testing in our Boston-based high complexity clinical laboratory. We believe this program will help solve many of the obstacles that are currently preventing the widespread testing that we so desperately need. Orig3n is incredibly excited to offer this solution to our state's nursing homes in service of their residents, many of whom are at high-risk. Orig3n's approach provides a model for the entire nation to make comprehensive testing happen."
Orig3n seeks to be the partner of choice for coordinating and providing COVID-19 testing for defined populations. The nursing home program is one of many applications for Orig3n's fully-integrated solution, including:
"As states and municipalities consider ways to get back to 'normal,' we see multiple phases to this process," said Mr. Smith. "Orig3n's fully-automated, high throughput laboratory and deep experience in sample collection logistics allow us to be the partner of choice for nursing homes, healthcare providers, employers, schools and other institutions nationwide."
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. 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. More details about the offering for nursing homes can be found at: https://orig3n.com/covid19/nursinghomes/.
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).
Orig3n exists at the intersection of biological science and emerging technology, on a mission to revolutionize the future of medicine. As part of its mission to democratize access to genetic information, Orig3n provides affordable direct to consumer testing as well as physician ordered, medical grade diagnostics. Orig3n also invests in breakthrough cell therapy programs by utilizing cutting-edge cellular science to develop personalized therapies for repairing tissue damage and treating disease. Orig3n's clinical diagnostic business provides COVID19 testing nation-wide. Since its inception in 2014, Orig3n has built the largest suite of direct-to-consumer genetic tests on the market, and the world's most comprehensive cell bank for commercial regenerative medicine applications. For more information, visit www.orig3n.com.
SOURCE Orig3n Inc.
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