News and reporting on EGFR biomarkers.
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 company has highlighted the study as evidence that its test would outperform Roche's FDA-approved liquid biopsy assay if implemented in the clinic.
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 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.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
In head-to-head studies, a next-generation EGFR inhibitor and an ALK inhibitor beat their older counterparts in staving of cancer progression.