Background: Despite advances in treatment for lung cancer, this disease remains challenging to manage. While cure through surgery is a desired goal, most patients present at an advanced stage, benefitting from biomarker-guided therapy. However, recent studies have found the median turn-around time for tissue-based mutation results was 12 days (range 1-54) for newly diagnosed patients and 27 days (range 1-146) for patients with acquired TKI resistance. Tissue availability and turnaround time can delay time to treatment for patients diagnosed with NSCLC.
Methods: To address the challenge of expediting biomarker test results and treatment, we have developed a lung reflex testing strategy, which uses the GeneStrat test using Droplet Digital PCR and the VeriStrat test using MALDI-ToF mass spectrometry. Both technologies are innovations in clinical laboratory testing. The ddPCR test delivers variant specific results for EGFR, KRAS, BRAF, ALK, RET and ROS1, while the proteomic profiling test provides prognostic data in EGFR subgroups. These multi-omic tests and generate more information from one blood-based sampling, reliably provide results in three days, and have been shown to be accurate.
Results: Since 2015, GeneStrat testing with the VeriStrat test as a reflex option for EGFR wild-type cases, have been utilized to analyze greater than 5,000 cases with greater than 94% of tests delivered in less than 72 hours. We will report on factors critical to the development and uptake of these tests in the clinic, including pre-analytic draw considerations for ambient specimen shipping, optimization of the Laboratory workflow and result review and generation.
Conclusions: Blood-based diagnostic tests for the rapid, reproducible and sensitive detection of both nucleic acid variants and proteomic profiles from one draw are highly suited for the demands of today’s clinical practice.