The US Food and Drug Administration (FDA) has granted approval for Agilent Technologies company Dako’s new companion diagnostic assay PD-L1 IHC 22C3 pharmDx.
The assay can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment.
The approval of the assay strengthens the company’s portfolio of companion diagnostics and its position in developing and commercialising companion diagnostic products.
PD-L1 IHC 22C3 pharmDx was developed by Dako in collaboration with Merck, which makes anti-PD-1 therapy Keytruda (pembrolizumab).
The FDA approved Keytruda to treat patients with metastatic NSCLC whose tumours express PD-L1 as determined by the companion diagnostic assay and have disease progression on or after platinum containing chemotherapy.
Keytruda is an immunotherapy that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, helping the immune system to help detect and fight cancer cells.
The drug can also cause the immune system to attack normal organs and tissues.
Agilent Diagnostics and Genomics Group president Jacob Thaysen said: "Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalised medicine, which is where PD-L1 IHC 22C3 pharmDx comes into play.
"This is a new era in immunoncology, and we are particularly excited about Agilent’s involvement in advancements in cancer treatment and the potential PD-L1 IHC 22C3 pharmDx has in helping to identify patients with non-small cell lung cancer who are most likely to benefit from treatment with Keytruda."
With the assay approved in the US, the company intends to secure regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year.
The company noted PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic assay that has been validated and approved to identify NSCLC patients eligible for Keytruda.
Merck Research Laboratories senior vice-president Dr Roger Dansey said: "The approval of the first PD-L1 diagnostic has the potential to provide information that will help guide treatment decisions for many patients.
"PD-L1 is an important new biomarker, and we look forward to working with Dako to make PD-L1 testing a routine part of the diagnosis and treatment of non-small cell lung cancer."