Clinical Genomics, a private biotechnology company developing next-generation diagnostic tools for colorectal cancer, and its partner in the China market, BioChain Group, have announced that they have received China Food and Drug Administration (CFDA) approval for InSure FIT.
InSure FIT is a fecal immunochemical test that was developed in Australia and is currently marketed and sold around the globe, including the US. Since 1999, more than 10 million people have been screened using InSure FIT.
Clinical Genomics VP, Asia Pacific, Warren Bingham, said the company is delighted with CFDA approval because it represents another international vote of confidence in the company’s cancer testing solutions.
“Screening for colorectal cancer is a major public health priority for countries around the world. Screening with fecal immunochemical tests is a guideline-endorsed option being adopted worldwide based on clear evidence that it will save lives. Governments are actively seeking affordable, effective and user-friendly cancer screening solutions for their communities.
"The InSure FIT ‘brush’ is easy to use and is designed for large screening programs. This test is ideal for large countries such as China with regional and remote communities that may not otherwise have accessible screening options,” said Mr Bingham.
According to BioChain Group’s Chairman and CEO, Mr James Wang, “This approval comes at an important time when China’s cancer screening program looks set to expand. We are excited to have the opportunity to introduce this effective and user-friendly test in China.”
To gain approval, BioChain completed an initial trial that was used as part of the approval package for the CFDA. The companies’ goal is to position the InSure FIT as being suitable for integration into the China Cancer Screening Program recently announced by the Chinese Government.