The NGS assay is designed to help physicians to identify non-small cell lung cancer patients who may benefit from eight targeted therapies.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The group plans to use the assay for translational studies on metastasis and drug resistance initially and to develop a clinical version later on.
The recent study highlights strengths and weaknesses of numerous platforms and may help end users choose the best assay for their circumstances.
Results from a recent study clarify some conflicting prior determinations, and provide a new rationale to further explore the FCGR2A biomarker in prospective trials.
The test helps to identify metastatic colorectal cancer patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective because their tumors carry no KRAS mutations.
The draft document, which includes recommendations on which molecular tests labs should perform, on what samples, and with what analytical specifications, is available for comment until April 22.