EGFR Biomarkers

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.

During the meeting, researchers presented studies on combination immunotherapies and the efficacy of giving molecularly-informed treatments earlier in the disease continuum.

The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.

The agreement will enable Biocartis to commercialize the EGFR S492R resistance mutation as part of its liquid and solid biopsy RUO assays.

The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).

Genome and RNA sequencing led to recurrent EGFR and BRAF rearrangements in cryptogenic congenital mesoblastic nephroma and infantile fibrosarcoma soft tumors.

The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.

The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.