Announcement #BGI: Bowel Cancer Detection Product Approved for Marketing in Saudi Arabia

Shanghai Securities News China Securities Network News (reporter Wang Zilin) BGI Gene announced at noon on January 7 that the bowel cancer auxiliary diagnosis products of BGI Europe A/S (hereinafter referred to as European Medicine), a wholly-owned subsidiary, were recently approved for listing by Saudi Food & Drug Authority (SFDA in English, Chinese translated as Saudi Arabia Food and Drug Authority).

The announcement shows that the kit is suitable for the qualitative detection of methylation of SDC2, ADHFE1, and PPP2R5C genes in human stool samples in vitro. This kit is suitable for the auxiliary diagnosis of patients recommended by clinicians for colonoscopy, and is for the reference of clinicians only, providing patients with an option of an adjuvant diagnostic method for colorectal cancer, and cannot be used as a basis for early diagnosis or diagnosis of tumors. Clinicians should make comprehensive judgments on test results based on factors such as the patient's condition and other laboratory testing indicators.

The 2020 Global Cancer (GLOBOCAN) Statistics Report shows that there are more than 1.9 million new cases of colorectal cancer each year, accounting for 10.0% of all new cancer cases; about 935,000 colorectal cancer deaths each year, accounting for 9.4% of all cancer deaths. Colorectal cancer is the third most malignant tumor in the world in incidence and second in mortality.

BGI said that the company's SFDA-approved detection product is for the detection of methylation markers related to the development of colorectal cancer in the human genome of human fecal samples, which is suitable for the auxiliary diagnosis of clinical colorectal cancer and has high sensitivity; the detection product can realize self-sampling, convenient and fast sampling methods and their non-invasive characteristics, which will help improve the ability to diagnose local bowel cancer in Saudi Arabia.

At the same time, the above products were approved by the SFDA for listing, which further expanded the company's influence and business scope in Saudi Arabia and even the entire Middle East, with a view to helping regional tumor prevention and control work and laying the foundation for long-term localization development and cooperation. In addition, the approval of this registration is another important achievement of the company's in-depth expansion of international layout and the sustainable development of overseas business, which is conducive to accelerating the company's global market share and further strengthening the international competitiveness of the company's products.