Skip to main content
Premium Trial:

Request an Annual Quote

China Approves Epigenomics Colorectal Cancer Test

NEW YORK (GenomeWeb) – Epigenomics and BioChain today announced the Epi proColon colorectal cancer detection test has been approved for marketing by regulators in China. 

The approval from the China Food and Drug Administration follows the completion of a clinical validation study by BioChain earlier this year that found the non-invasive blood-based test detected 75 percent of all cancer cases at 97.5 percent specificity. BioChain anticipates launching the test in the next few weeks through its distribution channels. 

The partners said that the availability of Epi proColon has the potential to expand colorectal cancer detection in China, "providing an early diagnostic tool to lower the CRC morbidity and mortality and reduce the cost in CRC prevention and therapy," while also increasing awareness of the importance of early screening, diagnosis, and intervention, "therefore enhancing the health of all Chinese people," BioChain Chairman James Wang said in a statement. 

Epigenomics is also seeking regulatory approval of the test by the US Food and Drug Administration. In June the company received a letter from the agency saying Epi proColon is not approvable. Since then, it has completed the design of the Adherence to Minimally Invasive Testing (ADMIT) study, which aims to demonstrate that the test will increase the participation of patients in colorectal cancer screening when offered the test, compared to those offered fecal immunochemical testing. 

The Scan

Close Panel Vote on Califf Nomination

The New York Times reports there was a close committee vote to advance the nomination of Robert Califf to lead the US Food and Drug Administration to the full Senate.

Task Force Reports on Scientific Integrity

Nature News writes that that a new task force report recommends that the US establish a cross-agency scientific integrity council.

Across the Hall

Genetic testing, closed-circuit cameras, and more show how a traveler, without any contact, infected others at a New Zealand quarantine facility, CNN reports.

Science Paper Examines Influence of Chromatin Modifications on Obsessive-Compulsive Disorder

In Science this week: genes regulating chromatin modification may contribute to OCD risk.