The researchers believe using cerebral spinal fluid will enable them to identify brain tumors with a higher sensitivity than with blood samples.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
The partners will use a $5M NCI grant to add seven biomarkers to an EGFR electrochemical assay for non-small-cell lung-carcinoma.
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 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).
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 company has highlighted the study as evidence that its test would outperform Roche's FDA-approved liquid biopsy assay if implemented in the clinic.
The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.