Medical technology company BD (Becton, Dickinson and Company) (NYSE:BDX), together with CerTest Biotec, a manufacturer of in vitro diagnostic medical devices, announced on Wednesday the receipt of the CE mark for the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX System.
According to the companies, the kit allows BD MAX System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV).
The BD MAX System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period. The CerTest test snaps into the test-specific position on the BD MAX ExK TNA extraction strip, supplied by BD.
VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX System and the VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX System are sold through BD's network and are not available for sale in the United States.
Pfizer reports positive Phase 3 data for ABRYSVO in adults at risk for RSV disease
D3 Bio announces Series A+ Round completion to advance innovative oncology pipeline
Dizal's sunvozertinib receives US FDA Breakthrough Therapy Designation
Merck launches Phase 3 trial of MK-1084 and KEYTRUDA combination in metastatic NSCLC
Trevi Therapeutics names new vice president of Clinical Development
Personalis validates NeXT Personal test for ultra-sensitive MRD detection
Merck reports lung cancer trial failed to meet endpoints
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib