BOSTON, June 23, 2020 /PRNewswire/ -- Orig3n, Inc., a Boston-based company pioneering the future of wellness and health through diagnostics, genetics and biotechnology, has announced a comprehensive solution to provide COVID-19 testing for boarding schools.
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).
"As educational institutions, including boarding schools, look to safely bring students and staff back to campus during the COVID-19 emergency, testing will be critical in attempting to ensure school safety," said Robin Y. Smith, President and CEO of Orig3n. "As with employers, nursing homes, cities and towns, schools are faced with the challenge of coordinating multiple suppliers and service providers to provide testing on the scale that is needed. 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 educational institutions nationwide. Orig3n's approach provides a model for the entire nation to make comprehensive testing happen."
"COVID-19 testing is a critical part of the re-entry process for boarding schools," said Adrianna Bravo, MD, Medical Director of Episcopal High School in Alexandria, Virginia, which is the first boarding school with which Orig3n agreed to implement this program. "Orig3n's solution provides both the gold standard RT-PCR diagnostic test and the on-site collection services. The quick turnaround time that Orig3n has is also critical for our school to be able to appropriately and safely return our students and employees to campus."
Orig3n seeks to be the partner of choice for coordinating and providing COVID-19 testing for defined populations. For more information about how boarding and day schools can safely come back to campus, go to www.orig3n.com/covid19/boardingschools. The boarding school program is one of many applications for Orig3n's fully-integrated solution, including:
- Employer Collection Events. As businesses reopen, Orig3n will partner with employers to coordinate and provide testing for workplaces. This can reduce the risk of workplace hazards associated with COVID19.
- School Populations. As primary, secondary and higher education institutions reopen in the Fall, Orig3n will partner with these institutions to implement comprehensive testing and risk management programs for their campuses.
- City and State Collection Events. Orig3n partners with cities and states to provide testing for large segments of the population at centralized testing locations.
- Government Agencies. As government offices reopen, Orig3n will partner with agencies to provide testing so that our public officials can resume providing critically important services to citizens.
- Nursing Homes and Assisted Living Facilities. Testing of residents and staff who may have been exposed to COVID-19 in an effort to protect this high-risk population.
"As we all adapt to a 'new normal,' Orig3n's fully-automated, high throughput laboratory and deep experience in sample collection logistics allow us to be the partner of choice for employers, nursing homes, schools and governments nationwide," said Mr. Smith.
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.
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.