FDA grants ThermoGenesis request to distribute antibody test kit, shares spike

The FDA said in a letter to ThermoGenesis dated October 17, "This is to notify you that your request pertaining to revise the distribution list for one additional authorized distributor, ThermoGenesis Holdings Inc. to market the Biohit Healthcare (Hefei) Co. Ltd.'s EUA authorized Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (EUA200192) under the device name of ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit is granted. Further, the extension of your expiration dates of the device up to 6 months and controls up to 5 months is also granted. The protocol for the validation of the new manufacturing facility provided by email on October 5, 2020 was found to be acceptable. Upon review, we concur that the data and information submitted in EUA200192/S002 and subsequent interactive review supports the requested updates for use with the Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit." Shares of ThermoGenesis spiked 18%, or 50c, to $3.26 in afternoon trading. Reference Link