EGFR

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.

An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.

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.