Pan Lung Cancer PCR Panel

Description:

The AmoyDx^® Pan Lung Cancer PCR Panel (PLC Panel) is a tissue-based, real-time, qPCR assay for in vitro diagnostics (IVD). The PLC Panel enables qualitative detection of up to 167 variants (85 DNA mutations and 82 RNA fusions) in 11 genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3), identifying all NCCN recommended biomarkers in a single PCR run. The PLC Panel is intended to assist in identifying clinically relevant biomarkers for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies at minimal cost. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

Principle:

The kit adopts Amplification Refractory Mutation System (ARMS) and real-time PCR technology, which comprises specific primers and fluorescent probes to detect NRAS mutations in human genomic DNA. During the nucleic acid amplification, the targeted mutant DNA is matched with the bases at 3’ end of the primer, amplified selectively and efficiently, then the mutant amplicon is detected by fluorescent probes labeled with FAM. While the wild-type DNA cannot be matched with specific primers, there is no amplification occurs.

Clinical Performance:

The clinical performance of PLC Panel was validated in a concordance study by LC-SCRUM-Japan.1 Results were highly concordant with the reference NGS assay for alterations (fusion, indels, SNVs) across 11 actionable biomarkers.

1. Matsumoto, S., et. al. Prospective concordance study of a multi-gene PCR assay and NGS for the detection of targetable gene alterations in lung cancer [abstract] in Journal of Thoracic Oncology. 2021 March; 16:3(S690): WCLC; 2020. Abstract P89.06.

Detected mutations:

EGFR (SNV/INDELS), HER2 (INDELS), KRAS (SNV), BRAF (SNV), ALK (FUSIONS), RET (FUSIONS), ROS1 (FUSIONS), NTRK1 (FUSIONS), NTRK2 (FUSIONS), NTRK3 (FUSIONS), MET (FUSIONS)

Sample requirement:

FFPE or fresh/frozen tissue minimum 67.5 ng DNA; minimum 120 ng RNA

Tests/kit: 8 (preloaded)

Instrument: QuantStudio™ 5, LightCycler® 480 II, cobas z 480