Four Novel Coronavirus testing products from four companies through a fast-track approval process
China's national medical products administration announced late on January 26 that it had approved four Novel Coronavirus testing products from four companies through a fast-track approval process. It will further expand the supply capacity of Novel Coronavirus nucleic acid detection reagents to fully serve the epidemic prevention and control needs.
Currently, four products, including Novel Coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method) and the 2019 novel coronavirus nucleic acid sequencing system, have been approved on an emergency basis. At the same time, provincial drug supervision departments have been required to strengthen the supervision and inspection of the above-mentioned product manufacturers to ensure product quality and safety.
In accordance with the conventional procedures, it takes 2-3 years of clinical trials before in vitro molecular diagnostic products into the hospital market. This time, the national medical products administration opened a green channel that only four days have gone through the process.
The national medical products administrationwill continue to adopt special approval procedures for drugs and medical devices needed for epidemic prevention and control, and strive for relevant products to be marketed as soon as possible.
Reported that four companies include: Shanghai zhijiang biological technology co., LTD. (hereinafter referred to as zhijiang organisms), national medicine group China Shanghai jie's biological technology co., LTD. (hereinafter referred to as the gateway), genomics technology (shenzhen) co., LTD. (hereinafter referred to as genomics), in shenzhen smart technology co., LTD. (hereinafter referred to as huada smart), after both for huada.
According to zhijiang, the newly developed kit USES multiple fluorescence PCR technology to simultaneously determine two independent genes of the new coronavirus by single tube double test, eliminating the risk of missed detection caused by virus variation. At the same time, the non-specific interference of SARS2003 strain and batsars-like strain can be excluded, and the 2019-ncov virus can be precisely targeted. The development of the new kit is a supplement to the product categories of its original coronavirus nucleic acid detection kit.
The kit is used for qualitative detection of novel coronavirus (2019-ncov) ORF1ab, N gene and E gene in in vitro samples of pharyngeal swabs, sputum and alveolar lavage fluid that require diagnosis or differential diagnosis of novel coronavirus infection in suspected pneumonia cases, suspected cluster cases and other patients with novel coronavirus infection.
After the outbreak of the epidemic, the relevant departments of the state intensified the supervision and control of novel coronavirus pneumonia treatment drugs and detection reagents. Chinese biology responded immediately and set up a leading group for the emergency prevention and control of novel coronavirus. The medical diagnosis sector of Shanghai zeno immediately put into research and development, after design, optimization and test, the first successful development of novel coronavirus nucleic acid molecular detection kit, and the first time sent to the Chinese center for disease control and prevention verification. Therefore, zhongshengzenuo has become the supplier of novel coronavirus pneumonia virus nucleic acid detection kit for multi-area disease control.
In addition to the above companies, shengxiang biological, fredray biological, berger medical, daan gene four enterprises also entered the state food and drug administration of the fast-track approval, is expected to receive formal approval in the near future.