Boston-based Orig3n has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its novel coronavirus detection test.
The healthcare providers and institutions across the world can use the Orig3n 2019 Novel Coronavirus (COVID-19) Test to identify the presence of nucleic acid from the virus, which causes COVID-19 disease.
The test has to be used with patients suspected of having contracted COVID-19, said the company.
Orig3n president and CEO Robin Smith said: “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.”
Orig3n’s COVID-19 test details
Orig3n’s test is a validated and real-time reverse transcription-polymerase chain reaction (RT-PCR) test, which helps in 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.
The test will provide the results between 24 hours and 36 hours upon the completion of procedures with the specimens at Orig3n’s Boston laboratory.
Smith further added: “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.”
Recently, Luminex has secured EUA status from the FDA for its ARIES SARS-CoV-2 Assay to rapidly detect the virus responsible for COVID-19 disease.
