Companion Diagnostics
News on companion diagnostics and drug/test co-development.
Agilent Technologies Nabs IVDR Certification for PD-L1 CDx
The PD-L1 IHC 28-8 PharmDx test is used to provide information on PD-L1 expression as a biomarker for patient response to therapies containing anti-PD-1 antibodies.
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.
Illumina to Incorporate Myriad's Genomic Instability Score Into Updated TSO 500 Cancer Assay
GIS measures DNA repair defects via loss of heterozygosity, large-scale state transition, and telomere allele imbalance.
Roche IHC Assay Nabs CE Mark as Companion Diagnostic for Abbvie's Elahere in Ovarian Cancer
The immunohistochemistry test detects the folate receptor 1 protein, which is over-expressed in most ovarian cancers.
Foundation Medicine Companion Dx Test Gets FDA OK for Use with Merck's Tepmetko in Lung Cancer
The blood-based comprehensive genomic profiling test uses next-generation sequencing to analyze 324 genes.