The DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR), the colorectal cancer early detection product under BGI’s wholly-owned subsidiary BGI Biotechnology (Wuhan) Co., Ltd., has recently obtained the medical device market access certification from Agencia Nacional de Vigilancia Sanitaria (hereinafter referred to as ANVISA), with a registration number 80117581027. Stool sample collection kit, DNA Isolation Kit and Sample Pretreatment Kit for Methylation Detection, which are used in conjunction with this detection product, were also recently approved by ANVISA with the registration number 80117581004, 80117581001 and 80117581000.
This detection kit (Real-Time PCR) is mainly used for the auxiliary diagnosis of colorectal cancer. Through qualitative detection of the methylation of SDC2, ADHFE1 and PPP2R5C genes isolated from human fecal samples, it determines the risk of colorectal cancer in the subject. The kit provides an auxiliary diagnostic method for colorectal cancer to those who are recommended by clinicians to receive diagnostic colonoscopy. Its high clinical accuracy, as well as its non-invasive and convenient characteristics, will enable it become one of the most important products for colorectal cancer detection in the future.
In recent years, the global incidence rate of colorectal cancer has been on the rise, and colorectal cancer (CRC) has become the third most common diagnosed cancer in the world, with more than 1.9 million new cases in 2020. According to the incidence rate estimates from the Brazilian National Cancer Institute, colorectal cancer was the second most common type of cancer among Brazilian men and women in 2020.
Because colonoscopy is invasive and requires adequate bowel preparation, although it is the gold standard for colorectal cancer diagnosis, the examination compliance is poor, and the participation rate of colonoscopy in the population is still not satisfactory. BGI’s colorectal cancer detection product can detect colorectal cancer only through human feces, which will greatly improve the compliance of population examination, achieve the goal of early detection, early diagnosis and early treatment, and reduce the disease burden of patients.
With the approval (or authorization) of ANVISA, BGI can provide Brazil with this detection product, promote Brazil¡¯s technology development of early detection of tumor and help with its early detection of colorectal cancer.