COLOTECT DNA Methylation Detection Kit Granted Australian Register of Therapeutic Goods Approval


BGI Genomics is pleased to announce that its proprietary COLOTECT DNA methylation-based test DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C GENES (Real-time PCR) has been listed on the Australian Register of Therapeutic Goods (ARTG) from Australia’s regulatory authority Therapeutic Goods Administration (TGA).

COLOTECT screens for colorectal cancer in adults aged 45 to 74. BGI Genomics’ qualitative technology can aid in early colorectal cancer and precancerous
lesions detection with higher sensitivity and accuracy compared to other non-invasive and commonly used Guaiac Fecal Occult Blood Test (gFOBT) or Immunochemical Fecal Occult Blood Test (iFOBT or FIT) screening tests. The sampling can be self-administered at home and then delivered to a clinical testing laboratory using a postal service, significantly reducing implementation expenditure and alleviating the strains on the public health system.

This non-invasive screening test revolutionizes the detection of colorectal cancer by leveraging advanced molecular analysis techniques, providing highly accurate
results with improved sensitivity and specificity. By offering a more accurate and reliable alternative to the existing conventional screening methods, COLOTECT
has the potential to significantly enhance early detection rates and save lives.

COLOTECT is a cutting-edge diagnostic tool designed to detect DNA methylation patterns in colorectal cancer. By analyzing DNA methylation, healthcare professionals can identify early-stage colorectal cancer and assess the risk of disease progression, enabling timely intervention and personalized treatment strategies.

The ARTG listing is a testament to the rigorous testing and validation processes undergone by COLOTECTBGI. It ensures that healthcare professionals and patients can trust the accuracy and efficacy of the test results. The TGA is an internationally recognized regulatory authority known for its stringent standards and commitment to public health and safety.

"We are delighted to receive TGA approval for COLOTECT, our innovative colorectal cancer screening test. The superior technical advantages of COLOTECT over existing conventional blood-based technologies set it apart as a game-changer in the field," said Mingyu Tian, General Manager of BGI Health (AU) Company Pty Ltd, an Australian subsidiary of BGI Genomics. "Our commitment to innovation and improving patient outcomes drives us to deliver cutting-edge solutions like COLOTECT that have the potential to revolutionize cancer screening.”

COLOTECT is now available in Australia, empowering healthcare professionals with a powerful tool in the fight against colorectal cancer. For more information about the kit, please contact BGI Genomics – Oceania at

About BGI Genomics

BGI Genomics, headquartered in Shenzhen, China, is the world's leading integrated solutions provider of precision medicine. Our services cover more than 100 countries and regions, involving more than 2,300 medical institutions. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.