China-based BGI Genomics' COLOTECT 1.0 DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C Genes (Real-Time PCR), Sample Pretreatment Kit for Methylation Detection, DNA Isolation Kit, Stool Sample Collection Kit have received market authorisation from Malaysia’s Medical Device Authority (MDA).
With this certification, COLOTECT 1.0 is now available in over six countries/regions and markets that recognise these certificates. COLOTECT 1.0 is eligible for EU market entry and has obtained MDMA in Saudi Arabia, MHRA registration in the UK, TFDA certification in Thailand, ANVISA certification in Brazil, Certificate of Listing in Hong Kong, and ARTG certificate in Australia. This flagship oncology product will help accelerate the company's international business growth.
COLOTECT 1.0 is a non-invasive, highly sensitive test for colorectal cancer (CRC) and precancerous lesions. Users could do this test from home to provide faecal samples for multi-methylation-specific PCR to detect abnormal CRC gene markers. Detecting the methylation status of exfoliated cell genes in the intestine helps detect colorectal cancer and precancerous lesions risk and colorectal cancer risk, even without active bleeding lesions.
Colorectal cancer is the third most common cancer and the second deadliest cancer globally. It is estimated that in 2020, colorectal cancer diagnoses worldwide were about 1.9 million.
