Recently, nine products of XIAMEN SPACEGEN CO., LTD., (hereinafter referred to as Spacegen ") including Human Endometrial Cancer Molecular Classification Detection Kit, Human PAX1 Gene Methylation Detection Kit and Human Lung Tissue Mycobacteria Identification Detection Kit have successfully obtained CE certification. This certification shows that our relevant products fully comply with international quality inspection standards, have professional guarantee in safety performance and quality indicators, and have obtained the pass to enter the markets of EU and EFTA countries.

As a leading enterprise in molecular diagnosis in China, since its establishment, Spacegen has successively won the EU CE-IVD certification for 20 products, which strongly confirms the technical strength and excellent product value of the company.

It is worth mentioning that the certified product " Human Endometrial Cancer Molecular Classification Detection Kit " has been tested comprehensively. In addition to the required POLE 9-14 exon, MSI and TP53 full CDs region, it also covers the full CDs region of MMR and EPCAM genes, as well as multiple extended genes such as CTNNB1, PIK3CA, KRAS and PTEN.

This time, 9 products achieved the whole process compliance certification, which opened a new situation for Spacegen‘s products to go oversea. In recent years, Spacegen has taken many measures to improve its ability to go oversea, from international exhibition exchanges to reaching cooperation agreements, and spared no effort to put its products on the "world stage".

At present, the global epidemic continues, and the road of the brand going oversea is doomed to twists and turns. As an opportunity to novel coronavirus pneumonia, the flying Spacegen will take the opportunity to face challenges, adhere to the ploughing and meticulous work in the field of molecular diagnosis, make contributions to the treatments of COIVD 19 ,cancer, innovate and expand the detection technology, accelerate the internationalization development strategy, create the world-class "hard core" product quality, and establish the "bio friendly" brand image.

CE certification

"CE" certification is a safety certification mark, which is regarded as the passport opened by the manufacturer and entered the European market.EU law puts forward a mandatory requirement for products: products circulating in the EU market, whether produced by enterprises within the EU or by other countries, must be affixed with the "CE" mark to indicate that the products meet the basic requirements of the EU new method of technical coordination and standardization directive.