Genetron Holdings Ltd., a precision oncology company, has reportedly announced the EUA (Emergency Use Authorization) for its SARS-CoV-2 RNA test from the U.S. FDA. It is a coronavirus detection kit that has been independently developed by the China-based company amid the outbreak.
In addition to this authorization, the export of this kit from the relevant Chinese authorities has also been approved.
The CCCMHPIE (China Chamber of Commerce for Import and Export of Medicines and Health Products) has whitelisted the company as an approved reagent manufacturer for COVID-19 testing. This signifies the approval for the company to export its detection kid for the novel coronavirus (SARS-CoV-2) RNA.
Genetron SARS-CoV-2 RNA Test, prior to being whitelisted by the CCCMHPIE and obtaining the EUA from FDA, had received the CE marking. It is a registration certificate given by Luxus Lebenswelt GmbH, the company’s representative in Europe. These certifications indicate the conformity of the products with safety, health, and environmental protection standards within the EEA (European Economic Area).
Genetron SARS-CoV-2 RNA Test offers a fast, accurate, and contamination-free testing solution and detects large-scale coronavirus samples. The features of the test include:
- Comprehensive and accurate testing: The RNA test is capable of detecting the ORF1ab and N, which are different & highly specific SARS-CoV-2 gene sequences that enhance its specificity and accuracy. Possible false results can also be prevented through its internal reference. Additionally, it can detect as low as 10 copies of RNA.
- Ability to efficiently operate in less duration: The test, with the One-Step Seq Method (patented technology), integrates the reverse transcription of the quantitative PCR reaction and viral RNA in one step over a period of less than 2.5 hours, with hands-on time of only 10 minutes.
- Contamination free: The dUTP and UDG application enables the system to degrade the PCR products that are non-specific and contaminated with nucleic acid.
The company has supplied the detection kit to a few high-risk regions across the globe to assist large-scale COVID-19 testing.