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Agilent Technologies Inc. (NYSE:A) just extended its diagnostics franchise into one of oncology's toughest corners. On July 23, the company said European regulators had certified its PD-L1 IHC 22C3 pharmDx test, Code SK006, as a companion diagnostic for epithelial ovarian, fallopian tube, and primary peritoneal carcinoma. That lets pathologists flag patients who might benefit from Merck's Keytruda. It is a narrow, technical-sounding approval, but it adds up to something bigger: Agilent's diagnostics business keeps racking up new indications while competitors scramble to keep pace.
Bull Case: A Diagnostics Machine That Keeps Adding Indications
This is now the eighth CE-marked indication for the 22C3 pharmDx ****** ay in the EU, following FDA approval of a related PD-L1 test (28-8 pharmDx) for esophageal and gastric cancers just nine days earlier. Each new label doesn't require Agilent to build a new product; it just extends the reach of an ****** ay already running in labs worldwide, which is a high-margin way to grow. Agilent has also been adding inorganically, closing its acquisition of Biocare Medical in June to deepen its clinical pathology reach, the same market where this new ovarian cancer approval lives. Together, the pipeline of regulatory wins and the acquisition strategy point to a company compounding its diagnostics footprint one label at a time rather than swinging for one blockbuster product.
Bear Case: A Crowded Diagnostics Field With A Scarier Neighbor
Companion diagnostics is not Agilent's alone to win. Danaher Corporation (NYSE:DHR), through its Leica Biosystems unit, competes directly for the same pathology lab budgets and just agreed on July 14 to acquire StatLab Medical Products to strengthen its own histology and AI-pathology pipeline. Danaher's own stock cratered 14% on July 21 after it trimmed its core revenue growth outlook, even though it beat on earnings and raised its profit forecast.
#pharmdx #pathology
Bull Case: A Diagnostics Machine That Keeps Adding Indications
This is now the eighth CE-marked indication for the 22C3 pharmDx ****** ay in the EU, following FDA approval of a related PD-L1 test (28-8 pharmDx) for esophageal and gastric cancers just nine days earlier. Each new label doesn't require Agilent to build a new product; it just extends the reach of an ****** ay already running in labs worldwide, which is a high-margin way to grow. Agilent has also been adding inorganically, closing its acquisition of Biocare Medical in June to deepen its clinical pathology reach, the same market where this new ovarian cancer approval lives. Together, the pipeline of regulatory wins and the acquisition strategy point to a company compounding its diagnostics footprint one label at a time rather than swinging for one blockbuster product.
Bear Case: A Crowded Diagnostics Field With A Scarier Neighbor
Companion diagnostics is not Agilent's alone to win. Danaher Corporation (NYSE:DHR), through its Leica Biosystems unit, competes directly for the same pathology lab budgets and just agreed on July 14 to acquire StatLab Medical Products to strengthen its own histology and AI-pathology pipeline. Danaher's own stock cratered 14% on July 21 after it trimmed its core revenue growth outlook, even though it beat on earnings and raised its profit forecast.
#pharmdx #pathology
