An optimized workflow for a fast molecular diagnosis of non-small cell lung cancer.

Abstract

e13139 Background: Lung cancer is the most common and lethal malignancy throughout the world, in which non-small cell lung cancer (NSCLC) is the dominant subtype. To distinguish between different cell types of NSCLC, i.e. adenocarcinoma or squamous cell carcinoma, the morphologic features of cancer cells are important, as well as specific molecular markers, i.e. TTF1, p63 and p40. Genomic studies have revealed different genetic aberrations between specific subtypes of NSCLC, and distinct response to targeted therapy. Therefore, molecular testing is essential for precision diagnosis and personalized treatment. The canonical workflow from diagnosis to next generation sequencing (NGS) tests needs about two weeks. Importantly, sometimes the residue material left after diagnostic staining may not be enough for NGS tests. This means a secondary biopsy is needed, which is not patient friendly. Methods: We optimized the canonical workflow by using BIOCO, a magnetic collector attached to microtome knife holder that can collect the abandoned tissue during slicing FFPE blocks. Therefore, the material used for NGS test was collected simultaneous during slicing for pathological diagnosis. In total 123 FFPE tumor blocks from suspicious NSCLC patients were included to evaluate: 1. how long it will take from diagnosis to make treatment decision? 2. If the material collected by BIOCO is sufficient for NGS test and whether the result can be trusted. Results: 1. The BIOCO workflow only needs 7 days for the diagnosis and making therapeutic plan. 2. The BIOCO could collect enough FFPE tissue for NGS test even with HE, IHC stanning and FISH test for all the samples; however, 14 samples failed NGS test because of insufficient material left following the canonical workflow. 3. the detection sensitivity and specificity of the BIOCO method are comparable with the canonical workflow, with a consistence of 94.9%. Conclusions: Here we propose an optimized workflow by using the BIOCO collector we invented, which shortens the canonical workflow from two weeks to one week, and it fully utilizes the limited biopsy tissue for NGS testing so that the secondary biopsies are avoided.