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The agency approved the new indication based on data showing that the drug improved survival in patients compared to chemotherapy.
The companies will work with labs to improve payors' understanding of the costs of performing PD-L1 testing and the value it provides to patient care.
The deal joins Indivumed's collection of tissue biospecimens and immunohistochemistry expertise with Ultivue's multiplex immunofluorescence platform.
The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.
A secondary analysis suggested that using NGS to identify patients with PTEN loss may be better than IHC in identifying best responders to treatment.
Patients with discordant p16 and HPV markers fall into an intermediate risk group, research presented at the European cancer conference suggests.
The company is hoping that ACE1702 will validate its antibody cell conjugation technology and show that its proprietary NK cells are more effective than current cell-based therapies.
Based on the expression of S100A2 and S100A4 proteins, researchers predicted which patients were likely to experience poor outcomes and disease recurrence post-surgery.
The companies hope to combine their technologies to provide pharmaceutical customers with an end-to-end workflow for multiplex histological staining and imaging.
The data add to growing evidence supporting the use of HER2 therapy across solid tumors, though researchers find a difficult path to a tissue-agnostic approval.