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Spacegen's Human EGFR Gene Mutations Detection Kit has been approved by NMPA

News source: Release time:[2019-06-11]

Good News-The Human EGFR Gene Mutations Detection Kit (Real Time PCR) developed by Spacegen have been approved by NMPA(National Medical Products Administration)on May 31,2019.



Product Intend Use

The kit is intended for the detection of 29 somatic mutations of EGFR gene in FFPE pathological tissue collected from patients with non-small cell lung cancer (NSCLC) or colorectal cancer.Patients with activating EGFR mutations, exon 19 deletion and exon 21 L858R point mutation are used for EGFR-TKI companion diagnostic.


Earlier, Spacegen’s Human EGFR Gene Mutations Detection Kit (Real Time PCR) have achieved CE-IVD certificate. This product has many advantages such as it can be sampled by one step, the detection can be finished in closed tubes, the results are accurate and reliable,etc.


Product NameTypes of CancerDetection Loci

Human EGFR GeneMutations Detection Kit

(Real Time PCR)

NSCLC

EGFR exon 18,19,21 mutations(coving 29 

target drug related loci)


Companion Diagnostic

Companion diagnostics (CDx)are used in selecting patient groups who can benefit from specific treatments with particular drugs. For its indispensable in drug and treatments, Companion diagnostic have become an important part of IVD.


In the past 10 years, the target treatment for NSCLC patients have made great achievements, especially the development of epidermal growth factor receptor target treatment. Currently, the first generation of target drugs such as Erlotinib, Gifetinib and Icotinib have been developed. The second generation of EGFR target drugs such as Afatinib, Dacomitinib have also been developed. The third generation of EGFR target drugs such as Osimertinib have been developed. There are more and more choice for patients. The life quality and patient’s treatment efficacy have been greatly improved.


EGFR target drugs

First generation of EGFR target drugs

NameEfficacy RatePFS
Gefitinib

IPASS M+ research has shown that Gefitinib 

VS Carboplatin+ paclitaxel=71% vs 47%

 

NE J002 research has shown that Gefitinib vs 

Carboplatin+ paclitaxel=74% vs 31%

 

WJTOG3405 research has shown that Gefitinib vs 

cisplatin+  Docetaxel=62% vs 32%

IPASS M+ research has shown that Gefitinib vs 

Carboplatin+ paclitaxel=9.5month vs 6.3 

month

 

NE J002 research has shown that Gefitinib vs 

Carboplatin+ paclitaxel=10.8 month vs 5.4 

month

 

WJTOG3405 research has shown that Gefitinib 

vs cisplatin +  Docetaxel=9.6month vs 6.6month


ISEL research has shown that in 342 Asian patients, Gefitinib group vs placebo group =9.5 month vs 5.5 month


Erlotinib

EURTAC research has shown that Erlotinib vs 

Carboplatin/ 

Cisplatin+ Gemcitabine/  Docetaxel =58% vs 15%

 

OPTIMAL research has shown that Erlotinib vs 

Carboplatin + Gemcitabine=83% vs 36%

EURTAC research has shown that Erlotinib vs 

Carboplatin/cisplatin+ Gemcitabine/  Docetaxel =9.7 

month vs 5.2 month

 

OPTIMAL research has shown that Erlotinib vs 

Carboplatin + Gemcitabine=13.7 month vs 4.6 

month



Second generation of EGFR target drugs

Name Efficacy RatePFS
Afatinib

LUX-LUNG3 research has shown that Afatinib vs 

Cisplatin +ALIMTA=61% vs 22%

 

LUX-LUNG6 research has shown that Afatinibvs 

Gemcitabine/ Cisplatin=66.9% vs23%

LUX-LUNG3 research has shown that Afatinib vs 

Cisplatin +ALIMTA=13.6 month vs 6.6 month

 

LUX-LUNG6 research has shown that Afatinib vs 

Gemcitabine/ Cisplatin=11 month vs 5.6month

Dacomitinib

ARCHER-1050 research has shown that Dacomitinib vs

 Gefitinib=76.3% vs 71.8%

ARCHER-1050 research has shown that Dacomitinib vs Gefitinib=14.7month vs 9.2 month


Third generation of EGFR target drugs

NameEfficacy RatePFS
Osimertinib

FLAURA research has shown that Osimertinib group vs

standard treatment group =77% vs 69%

FLAURA research has shown that Osimertinib 

group vs standard treatment group=18.9 month vs 

10.2 month


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