Business & Finance
Cervical Cancer Gains Companion Diagnostic with Expanded FDA Approval of Agilent's New Test
14 June 2018 - - Santa Clara, California application focused solutions provider Agilent Technologies Inc. (NYSE: A) has received approval from the US Food and Drug Administration (FDA) for its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use, the company said.
PD-L1 IHC 22C3 pharmDx is now the first FDA-approved immunohistochemistry (IHC) test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with Keytruda.
This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.
Agilent provides instruments, software, services, and solutions to the life sciences, diagnostics and applied chemical markets. The company generated revenues of USD4.47 bn in fiscal 2017 and employs 14,200 people worldwide.