Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July
Siemens Healthineers obtained clearances for four tests, including its N Latex FLC kappa and lambda reagents to diagnose multiple myeloma and other medical conditions.
Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug
The companies aim to develop the companion diagnostic for use with Henlius' investigational treatment for microsatellite instability-high solid tumors.
FDA Clears Promega Microsatellite Instability Test System
The OncoMate MSI Dx Analysis System is used to diagnose Lynch syndrome, a hereditary condition that increases cancer risk.
Promega Receives CE Mark for SARS-CoV-2 Antibody Test
The bioluminescent SARS-CoV-2 immunoassay enables scalable detection of antibodies against the receptor-binding domain antigen of the SARS-CoV-2 spike protein.
Promega to Develop MSI Assay as CDx for Incyte Endometrial Cancer Drug
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.