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K-ras Gene Mutations Detection Kit

(Real Time PCR)

CE-IVD


K-ras and Lung Cancer

Kristen murine sarcoma oncogene (K-ras) is the second most frequently mutated gene in patients with non-small cell lung cancer (NSCLC) in China, with a mutation frequency of 9.8%; about 30% of which are G12C mutations [1]. K-ras mutation is associated with poor prognosis (compared to wild type, HR=1.5, P=0.002) [1]. In May 2021, the FDA approved AMGEN's targeted anti-cancer drug Sotorasib for the treatment of adult patients with previously received at least one systemic therapy, K-ras G12C mutation, locally advanced or metastatic NSCLC.



K-ras mutation and prognosis [1]


[1] Biomark Res. 2020 Jun 25;8:22.


K-ras and Colorectal Cancer

Cetuximab and panitumumab are monoclonal antibody drugs that target epidermal growth factor receptor (EGFR), which can competitively prevent EGFR from binding to its ligand and inhibit its downstream signal transmission. K-ras is located in the Ras/Raf/MEK/ERK signaling pathway downstream of EGFR. The mutant K-ras protein does not depend on the regulation of EGFR, therefore, patients are resistant to cetuximab and panitumumab. The FDA specifically stated in the product instructions for cetuximab and Panitumumab that these drugs are not recommended for colorectal cancer patients with K-ras mutation.


Detection Items

No.Mutation TypeBase ChangesNO.Cosmic ID
1G12Dc.35G>AQ61Lc.182A>T
2G12Ac.35G>CQ61Rc.182A>G
3G12Vc.35G>TQ61Hc.183A>C
4G12Sc.34G>AQ61Hc.183A>T
5G12Rc.34G>CA59Tc.175G>A
6G12Cc.34G>TQ61Kc.181C>A
7G13Dc.38G>AA146Tc.436G>A
8
G13Cc.37G>TA146Vc.437C>T
G13Sc.37G>AA146Pc.436G>C
G13Rc.37G>C

K117Nc.351A>C

K117Nc.351A>T


Performance Parameter

Product NameTechnology

ProductSpecification

MatchedInstrumen

Sample Type

Human K-ras Gene 

Mutations Detection Kit

PAP-ARMS®10 tests/kit

Stratagene Mx3000P™,

ABI7500 etc.

tumor tissue,ctDNA,

pleural effusion


Detection Significance

1. It is recommended to detect K-ras gene status before systemic treatment for patients with inoperable stage III and IV NSCLC to guide the treatments according to molecular classification. If tissue samples are not available, circulating tumor DNA can be considered for testing. 

2. It is recommended to detect K-ras gene status for the potentially resectable group of metastatic colorectal cancer before neoadjuvant chemotherapy or systemic treatment in the palliative care group. The mutation patients are resistant to cetuximab, Panitumumab and anti-HER-2 therapies.



Technical Highlights


Accuracy and Reliability: Detection with closed tubes, avoid contamination.

High Sensitivity: Can detect K-ras gene mutations as low as 1% in 10 ng DNA samples. Comprehensive Detection: Covers 21 hotspot mutations on codons 12, 13, 59, 61, 117 and 146 of the K-ras gene.

Advanced Technology: R&D based on independent patented PAP-ARMS technology, one step operation.



Detection Process