Put It on the Board
Therascreen EGFR RGQ PCR kit approved as companion diagnostic for Vizimpro
October 2018—The FDA has approved a PMA supplement expanding the labeling claim of the Qiagen Therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib). Vizimpro is for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or an exon 21 L858R mutation. The Therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (afatinib) from Boehringer Ingelheim and Iressa (gefitinib) from AstraZeneca. It is registered in more than 40 countries. This was a project governed under an agreement between Qiagen and Pfizer.
Philips introduces computational pathology software for tumor detection
Royal Philips announced in September the latest release of TissueMark, which the company says now supports region of interest detection for the majority of molecular testing.