The three high-throughput sequencing platforms of SPACESEQ MEDLAB passed the 2023 China National Clinical Laboratory External Quality Assessment with full marks

The three high-throughput sequencing platforms of SPACESEQ MEDLAB passed the 2023 China National Clinical Laboratory External Quality Assessment with full marks

Recently, the National Center for Clinical Laboratory (NCCL) of the National Health Commission of China released the results report of "Bioinformatics Analysis of High-throughput Sequencing Detection of Tumor Somatic Mutations". According to the report, the Illumina sequencing platform, Ion torrent sequencing platform, and BGI sequencing platform of SPACESEQ MEDLAB all passed the proficiency verification with full marks, fully proving that SPACESEQ MEDLAB is capable of detecting biological information through high-throughput sequencing of tumor somatic mutations. In terms of scientific analysis, it has highly stable, professional and reliable detection capabilities.

SPACESEQ MEDLAB report card

Illumina Sequencing Platform

Ion torrent sequencing platform

BGI sequencing platform

It is reported that the national bioinformatics external quality assessment plan for high-throughput sequencing of tumor somatic mutation detection is an important means for the National Health Commission Clinical Laboratory Center to ensure the quality of clinical laboratory testing. This external quality assessment program can determine the ability of participating laboratories to detect bioinformatics by high-throughput sequencing of somatic mutations in solid tumors.

This external quality assessment mainly examines the ability of the laboratory to detect somatic mutation sites (SNV, Indel, CNV, SV) using NGS-based methods. SPACESEQ MEDLAB uses its own patented RingCap® high-throughput library construction method, and the detection results are completely consistent with the official expected results, which once again demonstrates SPACESEQ MEDLAB's ability in bioinformatics analysis of high-throughput sequencing detection of tumor somatic mutations and professionalism.

SPACESEQ MEDLAB is committed to high-throughput gene sequencing (NGS) technology to provide molecular diagnostic services for tumor precision medicine. The laboratory has established a sound quality management system and passed the ISO13485 medical device quality management system certification of TUV South Germany. At the same time, Feishuo Medical Inspection has actively participated in and passed the external quality assessment of NCCL, CAP, EMQN and other authoritative institutions at home and abroad for many consecutive times, and its testing technology has reached the international leading level.

Benefit public health

Xiamen SpaceGen Co., Ltd. was established in 2015. It is a national high-tech enterprise where leading entrepreneurial talents from the "Double Hundred Plan" of Xiamen City settled down. Relying on the four core technology platforms of high-throughput sequencing NGS, digital PCR, fluorescent quantitative PCR, and nucleic acid mass spectrometry, the company is committed to providing overall solutions for individualized and precise diagnosis of tumors, including early screening, disease diagnosis, and individualized drug guidance and curative effect monitoring and other fields, now has two medical testing laboratories, Xiamen SPACESEQ MEDLAB and Suzhou SPACESEQ MEDLAB, supporting a 3500m² GMP production workshop and a 2000m² R&D/quality control laboratory. The quality management system has passed the ISO13485 certification of TUV SÜD. SpaceGen has developed more than 40 products, 3 of which have obtained the National Medical Products Administration (NMPA) Class III medical device registration certificate, 7 products have completed the registration of Class 1 medical devices, and 22 products have obtained the EU CE-IVD certification.