China-based genomics giant BGI Genomics Co., Ltd (SHE: 300676) has reported receiving product approval from Brazil’s National Health Surveillance Agency (ANVISA) for its colorectal cancer (CRC) early detection real-time PCR product. The diagnostic kit, used for the auxiliary diagnosis of CRC, is a non-invasive product that detects human genes SDC2, ADHFE1, and PPP2R5C. The approval was granted to BGI’s subsidiary BGI Biotechnology (Wuhan) Co., Ltd. ANVISA has also issued approval for BGI’s stool collection kit, DNA isolation kit, and sample pretreatment kit for methylation detection for use alongside the diagnostic.
Kit Details and Impact
The kit provides an auxiliary diagnostic method for CRC for patients who are advised by a physician to receive diagnostic colonoscopy. CRC is increasingly prevalent globally, ranking as the third most common diagnosed cancer worldwide in 2020 with over 1.9 million new cases, and the second most common cancer among Brazilians. While colonoscopy remains the gold standard for CRC detection, patients can be reluctant to undergo the invasive test. The use of BGI’s non-invasive test is expected to help improve compliance and raise CRC detection rates.
Future Prospects and Strategic Implications
The approval from ANVISA marks a significant milestone for BGI Genomics in expanding its presence in the global diagnostics market. By introducing this non-invasive diagnostic kit, BGI aims to address significant unmet medical needs and improve patient outcomes in colorectal cancer detection.-Fineline Info & Tech
