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Pan-Cancer Drive Gene Mutations Detection Kit

(Next Generation Sequencing)

CE-IVD

GENE MUTATION AND TUMOR

Pan cancer driver gene mutation detection panel aims at the concomitant diagnostic genes approved by FDA and recommended by NCCN guidelines, covering 56 genes related to cancer treatment and prognosis, including 3000 cosmic mutation sites, so as to realize low-cost, high sensitivity and high-throughput gene detection of tumor tissue and blood free DNA of cancer patients.

Cancer is a complex polygenic disease caused by the gradual accumulation of gene mutations. When the genes regulating cell growth are mutated or damaged, the cells lose control and proliferate and differentiate disorderly and infinitely, leading to the occurrence of malignant tumors.

Cell. 2018 Apr 5;173(2):305-320.e10.

Tumor precise diagnosis and treatment products provide important reference basis for precise drug treatment, molecular typing and efficacy evaluation by accurately analyzing the unique gene mutation information of each tumor patient.

About NCI-MATCH

NCI-MATCH, also known as MATCH, is a precision medicine cancer treatment clinical trial. In this trial, people with cancer are assigned to receive treatment based on the genetic changes found in their tumors through genomic sequencing and other tests. Genomic sequencing is a laboratory method that is used to determine the genetic makeup of cancer cells. People whose tumors have genetic changes that match one of the treatments in the trial may receive that treatment if they meet other eligibility criteria. The trial seeks to determine whether treating cancer based on these specific genetic changes is effective, no matter the cancer type.

PRODUCT INFORMATION

Product Name

Core Technology

Number of Amplicons

Pack Size

Instruments

Validated

Sample Type

Pan-Cancer Drive

Gene Mutations

Detection Kit

RingCap®

213 DNA amplicons,

116 RNA fusion types

16 Tests/Kit

32 Tests/Kit

Ion Torrent,

Illumina

Tumor tissue samples,

peripheral blood

or Pleural effusion

DETECTION CONTENT

Gene Mutation	EGFR	KRAS	BRAF	PIK3CA	ERBB2
	MET	RB1	ALK	ERBB4	HNF1A
	MPL	SMAD4	ATM	FBXW7	IDH1
	SMO	CDH1	FGFR2	JAK3	NRAS
	STK11	CSF1R	FLT3	KDR	TP53
	ABL1	GNAS	PTPN11	AKT1	GNAQ
	MLH1	RET	APC	EZH2	HRAS
	NOTCH1	SMARCB1	FGFR1	JAK2	NPM1
	SRC	CDKN2A	FGFR3	IDH2	PDGFRA
	CTNNB1	GNA11	KIT	PTEN	VHL
	ALK	ROS1	RET	NTRK1	NTRK2
Gene Fusion	NTRK3
Gene Amplification	HER2	MET
Note: ERBB2 and MET include copy number variation detection.

DETECTION SIGNIFICANCE

Personalized Medication: Before using targeted drugs for malignant tumor patients, gene testing can be carried out to assist clinicians in judging the sensitivity of patients to drugs and evaluating the prognosis of patients.

FEATURES & ADVANTAGES

Ease of Use：With patented RingCap® technology, library preparation in 2 steps.

Fast Results： The library preparation takes only 3.5 hours, 2 working days from sampling to reporting.

High Sensitivity：The sensitivity can reach up to 1%.

Comprehensive Coverage：3000 kinds of cosmic mutation sites can be detected at one time.

DETECTION PROCESS

1.Nucleic Acid Extraction

2.Library Preparation （3.5 hours total time）

3.Sequencing

4.Auto-data Analysis

5.Report

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