GenScript Launches Novel Coronavirus Detection Assay

Assay enables development of reliable molecular diagnostics for faster treatments and vaccines

Piscataway, NJ /PRNewswire/ - GenScript, the world's leading gene synthesis provider, today announced the commercial launch of an assay for detecting the Wuhan novel coronavirus (2019-nCoV). The fast, one-step 2019-nCoV quantitative reverse-transcription polymerase chain reaction (qRT-PCR) detection assay, or reagent, is designed to make it easier and faster to develop reliable molecular diagnostics to identify and treat the virus, and vaccines to ultimately prevent infection.

"Detecting the Wuhan virus in individuals can be difficult due to the long incubation period and the varying degree to which they are symptomatic," said Hong Li, Ph.D., GenScript's Department Head of Reagent Services, R&D Department. "We have been working diligently to develop this assay for the global community, and we are pleased to launch it in the United States following its initial release in China. With standard, reliable assays for diagnosing the infection, clinicians will be better equipped to treat and hopefully stop the spread of the infection and save lives."

GenScript's 2019-nCoV qRT-PCR detection assay is an enhancement on the World Health Organization's (WHO) monoplex protocol published earlier this month after the virus was identified in Wuhan city in the Hubei Province of China. GenScript has developed a multiplex protocol that can detect two to three genes in one reaction, therefore accelerating the detection time of all three genes associated with the virus. GenScript's production facility also has ISO13485 certification for oligo production to address the needs of the molecular diagnostic companies interested in developing kits for approval in the U.S. market.

Although several coronavirus detection kits have been approved in China under expedited review, the U.S. Food and Drug Administration has yet to approve a diagnostic assay. Molecular diagnostics use DNA to identify pathogens more quickly and accurately than traditional culture-based methods, and can be particularly critical in the field of infectious diseases.

In response to 2019-nCoV epidemic, GenScript also prioritized 2019-nCoV- related gene orders for research organizations developing vaccines or treatments for the deadly virus. A list of plasmids carrying useful genes related to virus detection and vaccine research are also avialible through Molecularcloud, a GenScript-operated reagent repository: https://www.molecularcloud.org/How-to-detect-the-2019-novel-coronavirus.html

As a pioneer and leader in gene synthesis technology with over 600,000 completed gene synthesis projects for scientists around the world, GenScript is committed to providing the best support to the research community and to advancing biomedical research.

Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people such as with MERS and SARS. Chinese health authorities first identified cases of the novel Wuhan coronavirus, which has infected thousands in China and has spread to the U.S. and elsewhere internationally. The respiratory illness can be mild with cold-like symptoms or more severe, causing death often in people with underlying illnesses. More than 130 people have died to date.

About GenScript
GenScript is the world leader in biotechnology reagent services and biologics. Established in 2002 in New Jersey, United States, the company was the first to commercialize gene synthesis and successfully establish fully integrated capabilities for custom peptide synthesis, protein expression and engineering, custom antibody development and engineering, in vitro/in vivo pharmacology as well as a variety of catalogue products. GenScript has now expanded its business into immunotherapy, CDMO, laboratory equipment, and the microbial industry to further fulfill its mission to make humans and nature healthier through biotechnology. GenScript has also established open and innovative technology-driven platforms and GMP facilities for pre-clinical drug discovery and pharmaceutical product development.