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Biotech Company Psomagen COVID-19 Test Granted Emergency Use Authorization

The test accurately confirms coronavirus in two hours

Rockville, MD, July 06, 2020 (GLOBE NEWSWIRE) -- COVID-19 test services developed by Psomagen have been granted Emergency Use Authorization from the Food and Drug Administration on June 30, 2020. In response to the need for rapid and efficient testing, Psomagen’s test can confirm the presence of COVID-19 in a minimum of two hours. 

The Psoma COVID-19 RT Test from Psomagen is an in-vitro lab developed test (LDT) that uses real-time reverse transcription-polymerase chain reaction (RT-PCR) to provide fast, accurate results. Tests can detect RNA of the COVID-19 (SARS-CoV-2) nucleocapsid gene and RNaseP gene in upper respiratory and bronchoalveolar lavage specimens.

The test provides extremely high accuracy and can be used to screen patients with trace amounts of COVID-19. During Psomagen’s clinical trials for Psoma COVID-19 RT test, the company confirmed 100% consistency in both the positive and negative groups. Samples were collected from the upper and lower airways of COVID-19 patients.

The test services are to be fulfilled within Psomagen’s laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), by qualified clinical laboratory personnel trained in real-time PCR and in-vitro LDT procedures. Laboratories in the U.S. and its territories are required to report all results to the appropriate public health authorities.

The lab developed test relies on specimen collection from nasopharyngeal and oropharyngeal swabs. Once the swabs are collected according to CDC Interim Guidelines, total nucleic acids are extracted from patient specimens. The entire process is easy to deploy and reliable at target detection. 

Psomagen CEO Ryan Kim said, “The ability to quickly and accurately diagnose COVID-19 in a population is extremely important during the ongoing global pandemic, but the tests must also be able to detect future mutations of the virus. Our team is continuing to improve our test in order to detect these mutations and best serve the public.”

About Psomagen, Inc. 

Psomagen, Inc. offers cutting-edge genomic services through next-gen and Sanger sequencing and analysis services for accurate research data and clinical diagnostics. Founded in 2004 as a subsidiary of Macrogen, Inc. of South Korea, Psomagen is at the forefront of genetic and genomic analyses. Learn more at psomagen.com.

Susan Chung
Psomagen, Inc.
susan.chung@psomagen.com