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  • RANK 2025

    Visit us at the 19th edition of the RANK 2025 conference, which will take place on March 19th and 20th at the Zlatá Štika Hotel in Pardubice. The conference is organized by the Czech Society of Clinic...

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  • Kapras Day 2025

    We would like to invite you to the 23rd Kapras Day on the topic of  "Clinical Genetics," which will take place on Wednesday, February 26, 2025, in the Congress Hall of Hotel Olšanka in Prague. We loo...

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Pan Lung Cancer PCR Panel

Contact us

8.01.0247

CE-IVDD

8 tests per kit

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.

 

LC-SCRUM concordance analysis between PLC and reference NGS assay

 

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

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