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Xiamen Spacegen Co., Ltd.
No. 2041, Xizhou Road, Xike Town Tong'an District,
361100
Xiamen City, Fujian Province
China
China
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Contact
Sakina Zou
Ada Chen
Our range of products
Product categories
- 03 Diagnostic tests
- 03.06 Genetic testing, molecular diagnostics
- 03.06.02 Molecular biomarkers
Molecular biomarkers
- Human EGFR Gene Mutations Detection Kit (Real Time PCR) CE-IVD /NMPA Certified
- Human Oncology Multi-Gene Mutations Detection Kit (NGS) CE-IVD /NMPA Certified
- BRCA 1/2 Gene Mutation and Breast Cancer, Ovarian Cancer (NGS) CE-IVD
- Human B-raf Gene Mutation Detection Kit (Real Time PCR) CE-IVD
- Human K-ras Gene Mutations Detection Kit (Real Time PCR) CE-IVD
- 03 Diagnostic tests
- 03.06 Genetic testing, molecular diagnostics
- 03.06.03 Polymerase chain reaction (PCR)
Polymerase chain reaction (PCR)
- 03 Diagnostic tests
- 03.06 Genetic testing, molecular diagnostics
- 03.06.04 Other molecular diagnostics testing
Other molecular diagnostics testing
Our products
Product category: Molecular biomarkers, Polymerase chain reaction (PCR)
Human EGFR Gene Mutations Detection Kit (Real Time PCR) CE-IVD /NMPA Certified
- Gen status: Exon 18, 19, 21 mutations (19Del, L858R, G719X, S768I, L861Q), exon 20 mutation (T790M,20-Ins)
- Technology: Independent patented PAP-ARMS®
- Product Specification: 10 tests/kit & 20 tests/kit
- Matched Instrument: Stratagene Mx 3000, abi7500 etc..
- Sample Type: Tumor tissue silice, ct DNA, pleural effusion.
Product Highlights
Stable and Reliable:Closed tube detection, avoid contamination.
High Sensitivity: The detection can reach as low as 1% in 10 ng DNA.
Easy Operation: One step operation, only 90 minutes to finish the detection.
Good Reproducibility: Can be performed in the general PCR Labs. Results with good reproducibility canbe easily obtained without special training.
Product category: Molecular biomarkers, Other molecular diagnostics testing
Human Oncology Multi-Gene Mutations Detection Kit (NGS) CE-IVD /NMPA Certified
- Detected Genes:
* DNA: EGFR, KRAS, BRAF, PIK3CA, NRAS, HER2, MET, AKT1, c-KIT, PDGFRA
* RNA: ALK, RET, ROS1 - Core Technology: Independent patented RingCap®
- Matched Instrument: Ion Torrent, Illumina
- Sample Type: FFPE Tissue (10 sections, 5-10um at RT), ctDNA peripheral blood RNA (10ml at 4℃), pleural effusion(30-50ml at 4℃)
- Products Specifications: 16 tests/kit & 32 tests/kit
Advantages and Characteristics
Easy Operation: With independent patented RingCap® technology, library construction can be done in only two steps.
Rapid Detection: Library construction takes only 3.5 hours, only 2 working days from sample processing to reporting.
High Sensitivity:10000x sequencing depth. Up to 0.1% of sensitivity. Achieving the drug resistance monitoring for the liquid biopsy samples.
Comprehensive Detection: Detecting 13 mutated genes, covering 482 existing targeted drug-related COSMIC loci in one time. Comprehensive analysis the genetic information of non-small cell lung cancer andcolorectal cancer. To guide the use of targeted drugs which is recommended by the domestic and foreign authoritative institutions.
Detection significance
• Assist clinicians to select targeted drugs for patients.
• Predict efficacy and resistance of targeted drugs.
Product category: Molecular biomarkers, Other molecular diagnostics testing
BRCA 1/2 Gene Mutation and Breast Cancer, Ovarian Cancer (NGS) CE-IVD
- Detection of Genes and Loci: BRCA1 (Chromosome 17q21) & BRCA2 (Chromosome 13q12.3)
- Core Technology: Independent patented RingCap®
- Matched Instrument: Ion Torrent, Illumina
- Sample Types: Peripheral blood & tumor tissue
- Product Specification: 16 tests/kit or 32 tests/kit
Technical Highlights
Easy Operation: With independent patented RingCap® technology, library construction can be done in only two steps.
Rapid Detection: Library construction takes only 3.5 hours, only 2 working days from sample processing to reporting.
Accurate and Reliable: The targeting fragments are amplified by specific primers. Applicable to both paraffin embedded tissues and peripheral blood samples.
Comprehensive Inspection: As high-frequency mutant hotspots does not exist in the BRCA1/2genes, this kit achieves the whole exomes sequencing, ensuring the integration of the detection.
Detection Significance
1. Prediction
*The detection results can be used for the risk assessment of familial inherited breast cancer,and helping clinicians to select suitable prophylactic surgery or drugs.
2. Drug Guidance
*The breast/ovarian patients with BRCA 1/2 mutations will be more sensitive to orapani and other PARP inhibitors.
*The breast/ovarian patients with BRCA 1/2 mutations will be more sensitive to platinum-based treatments.
Product category: Molecular biomarkers, Polymerase chain reaction (PCR)
Human B-raf Gene Mutation Detection Kit (Real Time PCR) CE-IVD
- Detected Gene: B-raf V600
- Oncology: NSCLC & Colorectal Cancer
- Core Technology： PAP-ARMS®
- Matched Instrument: StratageneMx3000pTM, ABI7500 etc.
- Sample Type: tumor tissue Slice, ctDNA, pleural effusion
- Product Specification: 10 tests/kit
Stable and Reliable: Closed tube detection, avoid contamination.
High Sensitivity: The detection can reach as low as 1% in 10 ng DNA.
Easy Operation: One step operation, only 90 minutes to finish the detection.
Good Reproducibility: Can be performed in the general PCR Labs. Results with good reproducibility can be easily obtained without special training.
Applicable People
● A detection of B-raf gene status can be used to select targeted drugs (such as Vemurafenib) for patients with some kinds of tumor (such as melanoma) before starting the targeted treatments.
●A detection of B-raf gene status can be used to predict drug resistance before taking EGFR-TKI drugs.
Product category: Molecular biomarkers, Polymerase chain reaction (PCR)
Human K-ras Gene Mutations Detection Kit (Real Time PCR) CE-IVD
- Detection Items: Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys, Gly13Asp
- Matched Instrument: ABI7500, 7300, 7900, MX3000P, MX3005P, LC480
- Product Specification: 10 tests/kit
Detection Significance
● For the patients taking EGFR-TKI,the detection results of K-ras status can be used to predict the drug efficacy.
● For the patients with metastatic colorectal cancer, the detection of K-ras status is recommended before starting cetuximab treatment.
Technical Highlights
Easy operation: One-step operation. 90 minutes of the whole process.
High Sensitivity: Accurate detection of single copies of mutated DNA samples as little as10ng genome.
Good Reproducibility: Can be performed in the general PCR Labs. Results with good reproducibility can be easily obtained without special training.
Advanced Technology: R&D based on independent patented PAP-ARMS technology.
About us
Company details
Xiamen SpacegenCo., Ltd., integrating R & D, production, sales and advisory services, is dedicated to providing the most innovative products and services for cancer, genetic diseases and other personalized precision medical testing. We provide the products with total solution for early screening, disease diagnosis, personalized drug selection and efficacy monitoring of treatments.
Spacegen covers an area of 3500 ㎡GMP-compliant manufacturing plant,2000㎡R&D/QC lab and is equipped with high-throughput sequencing platforms, real time PCR platforms, digital PCR platforms and nucleic acid mass spectromrtry platform etc ., developing a series of personalized medical products based on the technology platforms mentioned above.
Spacegen has received EN ISO 13485 certification for medical device quality management. Eleven products have been achieved CE certification. CE certifications for more products are been applied now.
Core technology patent RingCap® has been authorized by the State Intellectual Property Office, and the other 19 domestic invention patents and 1 international invention PCT patent have been submitted.
Spacegen covers an area of 3500 ㎡GMP-compliant manufacturing plant,2000㎡R&D/QC lab and is equipped with high-throughput sequencing platforms, real time PCR platforms, digital PCR platforms and nucleic acid mass spectromrtry platform etc ., developing a series of personalized medical products based on the technology platforms mentioned above.
Spacegen has received EN ISO 13485 certification for medical device quality management. Eleven products have been achieved CE certification. CE certifications for more products are been applied now.
Core technology patent RingCap® has been authorized by the State Intellectual Property Office, and the other 19 domestic invention patents and 1 international invention PCT patent have been submitted.