Agilent Technologies IncEU approval for companion diagnostic expands market for Agilent's test.
Agilent Technologies has received European certification for its PD-L1 IHC 22C3 pharmDx test as a companion diagnostic for epithelial ovarian, fallopian tube, and primary peritoneal carcinoma, enabling pathologists to identify patients who may benefit from Merck's Keytruda. This marks the eighth CE-marked indication for the 22C3 assay in the EU, following an FDA approval of a related PD-L1 test for esophageal and gastric cancers nine days earlier. The approval extends the reach of an existing assay already used in labs worldwide, supporting Agilent's strategy of compounding its diagnostics footprint through incremental label expansions rather than relying on a single blockbuster product. The company also recently closed its acquisition of Biocare Medical to deepen its clinical pathology presence. However, Agilent faces competition from Danaher's Leica Biosystems, which is strengthening its own pathology pipeline with the planned acquisition of StatLab Medical Products, and the broader life sciences tools sector remains sensitive to growth outlook revisions, as seen when Danaher's stock fell 14% after trimming its core revenue growth forecast.
Agilent Technologies IncEU approval for companion diagnostic expands market for Agilent's test.
Danaher CorporationDanaher's stock fell after trimming core revenue growth forecast, and it faces competition from Agilent's approval.
Merck & Company IncApproval enables identification of patients for Keytruda, potentially increasing drug use.
Merck KGaALeica Biosystems is strengthening pipeline with StatLab acquisition, but impact not directly stated.
StatLab is being acquired by Leica, but no direct impact on StatLab's own operations mentioned.