ngs ONCO anti-EGFR Diagnostic Kit

This CE-IVD diagnostic kit is intended for target amplification of hot-spot areas in selected oncogenes relevant for target therapy of oncological patients (colorectal cancer, non-small cell lung cancer). It is designed to prepare a library of samples for sequencing on the Illumina MiSeq® platform. The kit includes free use of the very user-friendly ERMI evaluation software.

Cat. no. 3301-024	ngsONCO anti-EGFR	24 reactions
Cat. no. 3301-064	ngsONCO anti-EGFR	64 reactions

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Clinical implications

Diagnostic kit ngs ONCO anti-EGFR is a CE-IVD certified test that consists of a clinically relevant gene panel for target-therapy optimization of oncologic patients. It helps to determine suitability of deployed monoclonal antibodies Cetuximab (Erbitux) and Panitumumab (Vectibix) in colorectal cancer (CRC) that target EGFR (Epidermal growth factor receptor) protein by confirming/excluding mutations in KRAS, NRAS, and BRAF genes, because patients with these mutations do not profit from anti-EGFR treatment.

Parameters of the diagnostic kit

• Diagnostic kits for next-generation sequencing on Illumina MiSeq® platform
• Up to 64 samples per sequencing run (when used with v2 300 cycles chemistry)
• Panel of 8 relevant genes for molecular diagnostics of somatic mutations in colorectal cancer, lung cancer, and melanomas using the anti-EGFR antibody therapy
• Carefully designed primers for single-tube amplicon multiplex PCR library preparation providing uniform coverage
• Suitable with the FFPE samples and input DNA in amounts as low as 20 ng
• Straightforward library preparation protocol with short hands-on time
• Developed in collaboration with experts from the Clinic of Oncology, General University Hospital in Prague
• Bioinformatic software solution provides user friendly data analysis and generates a report

Kit Composition

	Compound	Purpose
	Master Mix 1
	Master Mix 2
	Primer Mix anti-EGFR	Multiplex PCR promer mix
	Primer F01-F08	Sample specific barcode sequence
	Primer R01-R08	Sample specific barcode sequence
	SP_Read1	Sequencing primer
	SP_IndexR1	Sequencing primer
	SP_Read2	Sequencing primer
	Magnetic beads	Library purification step
	Elution buffer	Library purification step

Panel of genes included in ngs ONCO anti-EGFR  diagnostic kit:

KRAS	chr 12	exon 2	exon 3	exon 4
BRAF	chr 7	exon 11	exon 15
NRAS	chr 1	exon 2	exon 3	exon 4
EGFR	chr 7	exon 18	exon 19	exon 20	exon 21
PIK3CA	chr 3	exon 21
AKT1	chr 14	exon 3
HER2	chr 17	exon 25
SMAD	chr 18	exon 12