Agilent Companion Diagnostic Gains Expanded FDA Approval in Cervical Cancer

Agilent Technologies (NYSE:A) announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use.

As quoted in the press release:

Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with KEYTRUDA, an anti-PD1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada).

PD-L1 IHC 22C3 pharmDx is now the first FDA-approved 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.

Click here to read the full press release.