According to the global cancer statistics GLOBOCAN (Sung et al., 2020), lung cancers are the leading cause of cancer mortality worldwide. With several ctDNA based early diagnostic and prognostic tests being developed for targeted therapies, the need for a preferred reference standard is paramount. Not all lung cancers share the same gene mutations hence, this panel will be supporting DNA mutations in Non-Small Cell Lung Cancer (NSCLC) which accounts for ~85% of all the lung cancer cases. This panel covers the significant DNA driver mutations responsible for NSCLC in EGFR, KRAS, BRAF and rare mutations in genes like MET, ERBB, PIK3CA, NRAS (see table below for mutation information). To aid in validations of liquid biopsy based companion diagnostic (CDx) tests, this panel is made in ctDNA format. With allelic frequencies as low as 0.30%, this panel can be used in validating assays designed for MRD testing.
Unlike synthetic reference materials, this panel is made with a unique blend of engineered cell lines mimicking patient samples, retaining the complexity of a biological sample. As always, all our reference standards are manufactured under ISO 9001:2015 and ISO 13485:2016.
Genes covered: EGFR, KRAS, BRAF, MET, ERBB2, PIK3CA, NRAS
COSMICs: 20. See table below for full details
Allelic frequencies: 0.30% - 1.20%
Buffer: Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.0
Fragment size: 160 bp
Unit size: 350 ng per vial
Concentration: 20 ng/µL
|Gene||COSMIC ID (v98)||DNA sequence change||Amino acid change||Expected allelic frequency (%)|
||COSM6108462||c.3802+1G>T||Unknown (Exon 14 skipping)||0.80|
Expiration: See all product shelf life information
Intended use: For assay developers, molecular diagnostic labs (Research use only)
Fragmentation size: D1000 DNA ScreenTape assay
Allelic frequency: Droplet Digital™ PCR
Quantification: Qubit® dsDNA BR assay (Invitrogen)
Kris MG, Camidge DR, Giaccone G, et al. Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors. Ann Oncol. 2015;26(7):1421-1427. doi:10.1093/annonc/mdv186
Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660
Certificate of analysis
The Non-Small Cell Lung Cancer ctDNA Panel Reference Standard negative control is well characterized, cell line-derived control material manufactured under ISO 9001:2015 and ISO 13485:2016 that is tested negative for 22 variants across 7 genes clinically relevant to NSCLCs.