Clinical Genomics and its Exclusive China Partner BioChain Group Receive CFDA Approval for InSure® FIT™ in China
Sydney, Australia and Beijing, China - Wednesday, March 02, 2016
Clinical Genomics, a private company developing next-generation diagnostic tools for colorectal cancer, and its strategic partner exclusive in the China market, BioChain Group announced today that they have received China Food and Drug Administration (“CFDA”) approval for InSure® FIT™, enabling the commercialization of InSure FIT throughout China. BioChain Group, via its Beijing-headquartered subsidiary, BioChain (Beijing) Science & Technology, Inc., is a leading diagnostics company active in the People’s Republic of China.
InSure FIT is a proven fecal immunochemical test that was developed in Australia and is currently marketed and sold around the globe, including the USA. 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 as this 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.
BioChain Group’s Chairman and CEO, Mr. James Wang said, “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.
About Clinical Genomics
Clinical Genomics is a privately held biotechnology company developing innovative products for colorectal cancer diagnosis. With a broad intellectual property portfolio consisting of more than 20 issued and pending patents, Clinical Genomics has developed a sensitive and specific blood test for colorectal cancer based on methylated DNA from two genes, BCAT1 and IKZF1, and plans to offer this 2-gene test for CRC recurrence monitoring in the U.S. beginning later in 2016. Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred colorectal cancer screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed in Australia and other countries (as ColoVantage Home).
Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as an FDA-registered and TGA-certified manufacturer and a NATA-accredited laboratory.
About BioChain Group
BioChain Group is a privately held technology company developing diagnostic products for various diseases and conditions. BioChain’s operations spans the United States and China, with offices in Silicon Valley and Beijing. BioChain US serves its worldwide customers in cutting edge research and development. BioChain Beijing is developing and commercializing diagnostics products and services for the greater China market. Several of BioChain’s product has obtained CFDA approval and are in current clinical use.