Non-Small Cell Lung Cancer Panel ctDNA Reference Standard

Improve your MRD assay validations using our new Non-Small Cell Lung Cancer ctDNA Reference Standard. It is a well characterized, cell line-derived control material manufactured under ISO 9001:2015 and ISO 13485:2016 that contains 22 clinically relevant variants across 7 genes.

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.

Technical data

Format: ctDNA

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

Product information

Fragment size: 160 bp

Unit size: 350 ng per vial

Concentration: 20 ng/µL

Verified mutations:

Gene	COSMIC ID (v98)	DNA sequence change	Amino acid change	Expected allelic frequency (%)
BRAF	COSM476	c.1799T>A	p.V600E	1.20
EGFR	COSM6239	c.2156G>C	p.G719A	0.50
EGFR	COSM6241	c.2303G>T	p.S768I	0.80
EGFR	COSM6213	c.2582T>A	p.L861Q	0.80
EGFR	COSM6224	c.2573T>G	p.L858R	0.80
EGFR	COSM6223	c.2235_2249del	p.E746_A750del	0.80
EGFR	COSM6225	c.2236_2250del	p.E746_A750del	0.80
EGFR	COSM12370	c.2240_2257del	p.L747_P753delinsS	1.00
EGFR	COSM6240	c.2369C>T	p.T790M	0.80
ERBB2	N/A	N/A	Amplification	6 copies
ERBB2	COSM20959**	c.2313_2324dup	p.Y772_A775dup	0.30
ERBB2	COSM12555	c.2331_2339dup	p.G778_P780dup	0.30
KRAS	COSM516	c.34G>T	p.G12C	1.00
KRAS	COSM520	c.35G>T	p.G12V	0.50
KRAS	COSM521	c.35G>A	p.G12D	1.00
MET	N/A	N/A	Amplification	4 copies
MET	COSM6108462	c.3802+1G>T	Unknown (Exon 14 skipping)	0.80
NRAS	COSM580	c.181C>A	p.Q61K	0.50
NRAS	COSM583	c.182A>T	p.Q61L	0.50
NRAS	COSM584	c.182A>G	p.Q61R	0.50
PIK3CA	COSM760	c.1624G>A	p.E542K	1.00
PIK3CA	COSM775	c.3140A>G	p.H1047R	0.8

**Alternate nomenclature c.2324_2325ins12 (p.A775_G776insYVMA) (Kris et al., Ann Oncol 2015)

General information

Storage: 4°C

Expiration: See all product shelf life information

Intended use: For assay developers, molecular diagnostic labs (Research use only)

Quality control

Fragmentation size: D1000 DNA ScreenTape assay

Allelic frequency: Droplet Digital™ PCR

Quantification: Qubit® dsDNA BR assay (Invitrogen)

References

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