Chinese precision oncology company Genetron Health has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its independently developed detection kit for the novel coronavirus.

The novel coronavirus detection kit, dubbed Genetron SARS-CoV-2 RNA Test, has also secured approval for export from the relevant authorities in China.

According to Genetron Health, the company was whitelisted as an approved Covid-19 reagent manufacturer by the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) to export its novel coronavirus test.

The company has already secured CE mark approval from the European representative Luxus Lebenswelt for the novel coronavirus test.

Genetron SARS-CoV-2 RNA Test has the capacity to detect large-scale samples for the novel coronavirus

Genetron SARS-CoV-2 RNA Test is a precise, rapid and contamination-free testing solution that holds the capacity to identify large-scale samples for the novel coronavirus.

The novel coronavirus detection kit can identify two different gene sequences of SARS-CoV-2, including ORF1ab and N.

The kit is also provided with an internal reference for the prevention of possible false-negative results. Each test holds the capacity to detect SARS-CoV-2 RNA as low as 10 copies.

By using the patented One-Step Seq Method, the process incorporates reverse transcription of viral RNA and quantitative PCR reaction in a single step.

The complete process is said to take less than two and a half hours, including 10 minutes of hands-on time.

The use of contamination resistant dUTP and UDG enzymes enables the system to degrade non-specific and nucleic acid-contaminated PCR products.

In addition, the company already distributed its novel coronavirus detection kit to some high-risk areas in the world.

In November 2019, Genetron Health secured approval from China’s National Medical Products Administration for its semiconductor-based next-generation sequencing (NGS) system.