Rapid On-Site Next-Generation Sequencing: An Alternative to Single-Gene and Send-Out Testing in Non-Small Cell Lung Cancer and Colorectal Cancer in a Community Pathology Laboratory Setting.

Non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) are malignancies with numerous actionable mutations. Accurate mutation identification is essential for targeted therapies, highlighting the need for next-generation sequencing (NGS). This study evaluated the Oncomine Precision Assay (OPA) as an alternative to single-gene panel (SGP) and send-out NGS (SO-NGS) testing in NSCLC and CRC. Turnaround time (TAT), quantity not sufficient (QNS) rates, and detection of National Comprehensive Cancer Network recommended alterations were compared. NSCLC alterations included EGFR, MET exon 14 skipping, ROS1, ALK fusions, RET fusions, ERBB2 mutations, NTRK1/2/3 fusions, BRAF, and KRAS p.G12C. CRC alterations included RET fusions, ERBB2 amplification, NTRK1/2/3 fusions, BRAF, KRAS, NRAS, and microsatellite instability. A total of 74 NSCLC and 72 CRC cases were analyzed concurrently with OPA and SGP and compared with historical SO-NGS data from 163 NSCLC and 49 CRC cases. OPA demonstrated broader mutation coverage than SGP, detecting all evaluated NSCLC alterations and most CRC alterations, while SO-NGS provided the most comprehensive coverage overall. In both NSCLC and CRC, OPA mean TAT was shorter when compared with SGP and SO-NGS. OPA also demonstrated lower QNS rates and comparable or improved detection rates, supporting its use for community-based molecular testing in NSCLC and CRC.