EGFR Biomarkers

The researchers found that most advanced EGFR-mutant lung cancer patients harbored changes in an average of two to three other oncogenes.

The kit detects 29 mutations in exons 18, 19, 20, and 21, and has a limit of mutation detection at .1 percent in a background of wild-type DNA.

The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology. 

The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.

The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments. 

The company will work with USC researchers in a year-long study aimed at assessing the clinical utility of EntroGen's PCR-based liquid biopsy test for EGFR mutations.

The lung cancer test, which can detect 51 EGFR mutations, is the fifth assay for cancer that the Belgian molecular diagnostics firm has CE marked.