As a medical device registrant, the company is carrying out the research and development and clinical trials of two diagnostic kit projects according to the implementation plan of Shandong medical device registrant system pilot work. The progress is as follows:
(1) The project of padi2 plus PADI4 multiple ELISA tumor detection kit was approved by Shandong Provincial innovation project precision medicine project (2017cxgc1202). At present, clinical trials are being carried out, and the medical device certificate is being applied for.
(2) The project "Research on clinical transformation and industrialization of early rapid diagnosis kit for Alzheimer's disease" was approved by Shandong provincial key R & D plan (2019jzzy011011). At present, it is commissioning manufacturers to trial produce clinical products and prepare for clinical trials.
