SpaceGen

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XIAMEN SPACEGEN Co., Ltd. (abbreviated as “SPACEGEN”) is a high-tech molecular diagnostic biology enterprise integrating R&D, production, sales and service. The company leads technological innovation guided by clinical needs ，providing high-quality and accessible molecular diagnostic products and services, covering the whole-cycle of cancer management , including early screening, disease diagnosis, individualized medication guidance and continuous curative effect monitoring.

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Discover our range of products to best fits your application needs.

B-raf Gene Mutations Detection Kit (Mutiplex Fluorescence PCR)

BRAF gene plays an important role in signal transduction involving cell proliferation, by regulating various kinds of cellphysiological activities, such as growth, division , death etc. Mutations of BRAF occurred in manycancers such as malignant melanoma,colorectal cancer, lung cancer, thyroid cancer, liver cancer,etc. Detection Significance/ Applicable People ● Patients with suspected Lynch syndrome can be checked by BRAF genetic detection. ●Can be used for the identification of diagnosis for thyroid cancer, assessing the prognosis for malignant melanomaand colorectal cancer. ● For patients treated with BRAF and EGFR inhibitors, detection of BRAF gene mutation status can be used to adjustdiagnosis and treatments.

BRCA1/2 Gene Mutations Detection Kit（Next Generation Sequencing）

According to the Breast Cancer Information Core (BIC), there are more than 3,000 kinds of BRCA1 and BRCA2 gene mutations, distributing throughout the whole coding region. The most common types of pathogenic mutations are frameshiftmutations, nonsense mutations, while there are no obvious mutation hotspots. Most mutations lead to the formation oftruncated proteins, by which resulting in the loss of BRCA1 or BRCA2 protein function and lead to the occurrence of tumor. Detection Significance 1. Assess family genetic risk and provides comprehensive, accurate, professional and precise diagnosis for tumordiagnosis and treatment. 2.To evaluate the response of patients with BRCA1 / 2 mutant malignant tumors to PARP inhibitors such as olapani.

EGFR Gene Mutations Detection Kit (Mutiplex Fluorescence PCR)

Epidermal growth factor receptor (EGFR) is a receptor tyrosine kinase, expressed in 50% of non-small cell lung cancer(NSCLC), which is closely related to the occurrence and development of tumors. EGFR gene mutation is the most important predictor of the efficacyof EGFR kinase inhibitors (TKI) and is a prerequisite for clinically determining whether patients can use EGFR-TKI therapy. Boththe National Comprehensive Cancer Network (NCCN) and the Chinese Society of Clinical Oncology (CSCO) guidelinesinclude EGFR mutation detection as a category 1 recommendation. Clinical Significance 1. The detection of EGFR mutation for stage II/III non-squamous cell carcinoma after operation can help guide adjuvating targeted therapies. 2. The detection of EGFR mutation for inoperable stage III and IV NSCLC patients, can help guide the treatmentsaccording to molecular classification. 3. For patients with EGFR-TKI resistance, it is recommended to perform another biopsy for EGFR gene mutation detection.

K-ras Gene Mutations Detection Kit (Mutiplex Fluorescence PCR)

Kristen murine sarcoma oncogene (K-ras) is the second most frequently mutated gene in patients with non-small cell lungcancer (NSCLC) in China, with a mutation frequency of 9.8%; about 30% of which are G12C mutations. K-ras mutation isassociated with poor prognosis (compared to wild type, HR=1.5, P=0.002). Clinical 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.

Oncology Multi-Gene Mutations Detection Kit（Next Generation Sequencing）

Detection Significance ● Personalized Treatment：Select suitable target drugs for the patients based on the gene detection informationto improve the efficacy of the drugs, thus realize personalized treatment. ● Monitoring drug efficacy and resistance: Analyze the drug resistance mechanism, adjust the treatment planaccording to the gene variation information after drug resistance.

Thyroid Carcinoma RET Gene Fusions Detection Kit (Mutiplex Fluorescence PCR)

The RET proto-oncogene is located at 10q11.2, is 60 kb in length, and contains 21 exons. After the RET gene is fused, thedimerization can be completed without ligands, resulting in the RET tyrosine kinase region, downstream Ras/Raf/MEK/ERK,PI3K/AKT and other signal pathways are continuously activated. It continues to drive cell proliferation, migration and differentiation etc., which will cause the occurrence of tumors. RET is one of the most common driver genes for papillary thyroidcarcinoma (PTC).13 different oncogenic RET/PTC fusion proteins have been discovered. Among them, RET/PTC1accounts for about 60% of RET-related PTC, RET/PTC3 accounts for about 30%, and RET/PTC2 accounts for about 10%. Theremaining RET/PTC family members are extremely rare. Detected Significance 1.FNA samples of thyroid nodules, coarse needle puncture samples or surgical resection samples for RET gene fusiondetection can help assist in the diagnosis of PTC. 2. Patients with unresectable, refractory iodine, locally recurring or metastatic thyroid cancer should be tested for RETgene fusion status to help guide treatments.