BGI has begun to market its reverse transcription polymerase chain reaction (RT-PCR) test for the novel coronavirus in the U.S., ahead of securing emergency use authorization (EUA) from the Food and Drug Administration (FDA).
The company's real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 already has the European CE-IVD Mark and clearance from China's National Medical Products Administration (NMPA). Its turnaround time is three hours, and it is being distributed in more than 50 countries around the world, BGI said.
Amid criticism about the lack of access to testing in the U.S., the FDA announced on March 16 that it was loosening requirements related to the introduction of diagnostic products for the novel coronavirus. Per its latest guidance, commercial test developers may sell their products without an EUA. BGI said it has been submitting information about the product to the FDA and expects to get a formal EUA "in the near future."