Dako Receives FDA Approval for Lung Cancer Assay

Agilent Technologies subsidiary Dako has received FDA approval for a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer is likely to respond to a new form of treatment.

The diagnostic, PD-L1 IHC 22C3, aims to identify patients with non-small cell lung cancer who are most likely to benefit from treatment with Keytruda, a Merck & Co. anti-PD-1 therapy.

“Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalized medicine,” said Jacob Thaysen, president of Agilent’s Diagnostics and Genomics Group.

Dako hopes to gain regulatory approval for the assay in Canada, Europe and other jurisdictions next year. — Michael Cipriano