NEW YORK – GenScript BioTech BV announced on Wednesday that it has signed an exclusive distribution agreement with IES Diagnostics to distribute GenScript's SARS-CoV-2 antibody kit in Spain, Portugal, and Andorra.
The GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit measures the presence of neutralizing antibodies in patients either recovering from COVID-19 or receiving a vaccine against the virus, Leiden, Netherlands-based GenScript BV said in a statement. Results from human serum and plasma are provided in about an hour.
The blocking ELISA detection assay received Emergency Use Authorization from the US Food and Drug Administration in November and was the first SARS-CoV-2 neutralizing antibody test to receive EUA. It has also received CE marking, clearance from the Ministry of Health and Prevention in the United Arab Emirates, Health Sciences Authority provisional approval in Singapore, and regulatory approval in Brazil and Argentina.
The kit "will contribute decisively to the knowledge of the immune status and level of protection of both those who have suffered a SARS-CoV-2 infection and those citizens who have been or will be vaccinated," said IES Medical CEO Hubert Thomassen. IES Diagnostics is the life science division of IES Medical, headquartered in Bilbao, Spain.
GenScript BV is a subsidiary of GenScript Corp.