Rendu Gets NMPA's Emergency Approval For Coronavirus Nucleic Acid Detection System

SHANGHAI, March 30, 2020 /PRNewswire/ -- Rendu Biotechnology today announces that China's National Medical Products Administration (NMPA) has granted emergency approval to Rendu's coronavirus 2019-nCoV nucleic acid detection kit (hereinafter referred to as "2019-nCoV detection kit"). This is the only RNA capture probe nucleic acid detection kit that has been approved by the Chinese regulator so far.

Rendu is the first Chinese high-tech company that focuses on RNA molecular diagnostic technology. Rendu is one of the few R&D-driven Chinese biotech companies with global competitiveness.

As stated on the NMPA website, the "2019-nCoV detection kit" uses RNA-specific target capture and transcription-mediated constant temperature amplification real-time detection technology. Nucleic acid extraction and amplification steps are completed automatically in one reaction tube. It takes 90 minutes to produce the results; continuous and parallel detection can be realized, which improved detection efficiency. Data show that the sensitivity and specificity of the detection results can reach the level of traditional PCR methods.

In addition to the detection kit, Rendy also launched AutoSAT, a fully automatic, high-throughput, and full-process integrated platform for coronavirus nucleic acid detection.

Nucleic acid testing serves as definitive etiological evidence and plays a decisive role in the investigation of suspected patients. Usually, the virus nucleic acid tests require samples to be sent to a centralized laboratory for testing. A large number of to-be tested samples, complicated operation steps, lack of medical staff, all of these increase the risk of infection and prevent test results to be produced in a timely manner. The AutoSAT platform can lessen these issues to some extent.

The AutoSAT platform is a product that integrates nucleic acid extraction, amplification reactions, and results reporting. Simply put the to-be-tested sample tube in AutoSAT, the instrument's nucleic acid extraction, purification, amplification detection, and reporting results are all done automatically by the instrument. The samples do not need to wait for the batch to come out. They can be inspected at any time (a single sample is on the machine at any time). It took only 90 minutes to produce the first result and averagely 2 minutes for the subsequent results. Operators can operate multiple instruments simultaneously. One instrument can complete 200 tests in 8 hours and 700 tests in 24 hours. It is especially suitable for on-site and rapid investigation of overseas imported coronavirus cases and large-scale samples of medical institutions.

The kit is equipped with a unique sample preservation solution, which can inactivate the virus and keep the RNA at a normal temperature for a long time without degradation. This will reduce false-negative results due to sample degradation, and dramatically reduce biosafety risks during transportation and testing. After the samples reach the laboratory, the original tube is directly tested on the machine.

As of March 27th, the NMPA has granted 23 emergency approvals to coronavirus detection products and eight antibody detection reagents.

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SOURCE Rendu Biotechnology